taro pharmaceuticals u.s.a., inc. - Medication Listings

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N -methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO∙HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride is a white or almost white powder. Each scored tablet contains fluoxetine hydrochloride equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: hypromellose 2910 (3 mPas), hypromellose 2910 (6 mPas), magnesium stearate, maize starch B, mannitol, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone K30, and titanium dioxide. Chemical Structure

Purpose Pain reliever/fever reducer

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Uses Relieves dryness and softens cold sores and fever blisters Softens crusts (scabs) associated with cold sores and fever blisters

Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11β,17, 21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone valerate foam, 0.12%, contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of alcohol (60.4%), cetyl alcohol, citric acid anhydrous, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure

Bumetanide, USP is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (light pink) tablets for oral administration; each tablet also contains lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 Lake, FD&C Blue No. 1 Lake and FD&C Red No. 40 Lake; 1 mg—D&C Yellow No. 10 Lake; 2 mg— D&C Yellow No. 10 Lake and FD&C Red No. 40 Lake. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula: Meets USP Dissolution Test 2. Chemical Structure

Butalbital, acetaminophen, and caffeine capsules are supplied in hard-gelatin capsule form for oral administration. Each capsule contains: Butalbital, USP Warning: May be habit-forming. 50 mg Acetaminophen, USP 300 mg Caffeine, USP 40 mg In addition, each capsule contains the following inactive ingredients: microcrystalline cellulose, povidone, stearic acid and talc with capsule shell composed of FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: Butalbital C 11 H 16 N 2 O 3 MW: 224.26 Acetaminophen (4´-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Acetaminophen C 8 H 9 NO 2 MW: 151.16 Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula: Caffeine C 8 H 10 N 4 O 2 MW: 194.19 Chemical Structure Chemical Structure Chemical Structure

Calcipotriene ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola- 5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.6, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Calcipotriene ointment contains calcipotriene 50 μg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, α-tocopherol, steareth-2 and purified water. Structural Formula of Calcipotriene

Calcitrene ® (calcipotriene) ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.6, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Calcitrene ® (calcipotriene) ointment, 0.005% contains calcipotriene 50 µg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, α-tocopherol, steareth-2 and purified water. Chemical Structure

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic, lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α - D -galacto -octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 g/mol Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, dehydrated alcohol, polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure

Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water. May contain sodium hydroxide for pH balance. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). Chemical Structure

Table 4. Description Established Name: Clobazam Tablets Dosage Form: Tablet Route of Administration: Oral Established Pharmacologic Class of Drug: Benzodiazepine Chemical Name: 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4( 3H,5H) -dione Structural Formula: Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. The melting range of clobazam is from 182°C to 185°C. The molecular formula is C 16 H 13 O 2 N 2 Cl and the molecular weight is 300.7. Each clobazam tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: colloidal silicone dioxide, lactose monohydrate, magnesium stearate, pregelatinized maize starch, and talc. Chemical Structure

Table 4. Description Established Name: Clobazam Dosage Form: Oral Suspension Route of Administration: Oral Established Pharmacologic Class of Drug: Benzodiazepine Chemical Name: 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4( 3H,5H )-dione Structural Formula: Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. The melting range of clobazam is from 182°C to 185°C. The molecular formula is C 16 H 13 O 2 N 2 Cl and the molecular weight is 300.7. Clobazam is available for oral administration as an off-white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include artificial raspberry flavor, citric acid monohydrate, magnesium aluminum silicate, maltitol solution, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium phosphate dibasic heptahydrate, sucralose, xanthan gum. Chemical Structure

Clobetasol propionate foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25 H 32 CIFO 5 , a molecular weight of 466.97. The following is the chemical structure: Clobetasol propionate is a white to almost white crystalline powder, practically insoluble in water. Each gram of clobetasol propionate foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid anhydrous, dehydrated alcohol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure

Clocortolone pivalate cream USP, 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of benzyl alcohol, carbomer homopolymer Type B (carbopol 974P), edetate disodium, methylparaben, mineral oil, polyoxyl 40 stearate (MYRJ 40S), propylparaben, purified water, sodium hydroxide, stearyl alcohol and white petrolatum. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16αmethylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Chemical Structure

Chemically, clorazepate dipotassium USP is a benzodiazepine. The empirical formula is C 16 H 11 ClK 2 N 2 O 4 ; the molecular weight is 408.92; 1 H -1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows: The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium oxide heavy, magnesium stearate, microcrystalline cellulose, potassium carbonate anhydrous, potassium chloride, talc and the following coloring agents: 3.75 mg - FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake 7.5 mg - D&C Red No. 6 Barium Lake and D&C Yellow No. 10 Lake 15 mg - D&C Red No. 6 Barium Lake and FD&C Red No. 40 Lake Chemical Structure

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C 22 H 17 CLN 2 , a molecular weight of 344.84, and the following structural formula: Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.59, and the following structural formula: Betamethasone dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative. Chemical Structure Chemical Structure

Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 mg and 100 mg for oral use. Inactive Ingredients: colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Chemical Structure

Desonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17[(1methylethylidene) bis(oxy)]-,(11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide is C 24 H 32 O 6 . It has the following structural formula: Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of desonide lotion contains 0.5 mg of desonide in a base of cetyl alcohol, diethylene glycol monoethyl ether, edetate disodium, glyceryl stearate/polyethylene glycol, light mineral oil, methylparaben, purified water, propylene glycol, propylparaben, sodium lauryl sulfate, sorbitan monostearate and stearyl alcohol. Contains citric acid monohydrate and sodium hydroxide for pH adjustment. Chemical Structure

Diclofenac potassium for oral solution, USP is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium, USP is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monopotassium salt. The molecular weight is 334.2 g/mole. Its molecular formula is C 14 H 10 Cl 2 KNO 2 , and it has the following chemical structure. The inactive ingredients in diclofenac potassium for oral solution, USP include: aspartame (equivalent to 25 mg phenylalanine), flavoring agent (peppermint), glyceryl dibehenate, mannitol, potassium bicarbonate, and saccharin sodium. Chemical Structure

Enalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[ N -[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z) -2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 ∙C 4 H 4 O 4 , and its structural formula is: Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and the 20 mg tablets also contain iron oxide red. Chemical Structure

Enalapril maleate and hydrochlorothiazide combines an angiotensin converting enzyme inhibitor, enalapril maleate, and a diuretic, hydrochlorothiazide. Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as ( S )-1-[ N -[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, ( Z )-2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 ∙C 4 H 4 O 4 , and its structural formula is: Enalapril maleate is a white to off-white crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Enalapril maleate and hydrochlorothiazide is available in two tablet combinations of enalapril maleate with hydrochlorothiazide: enalapril maleate and hydrochlorothiazide 5/12.5 mg, containing 5 mg enalapril maleate and 12.5 mg hydrochlorothiazide and contain the following inactive ingredients: ferric oxide black, ferric oxide yellow, lactose monohydrate, magnesium stearate, pregelatinized starch, purified water, and sodium bicarbonate. Enalapril maleate and hydrochlorothiazide 10/25 mg, containing 10 mg enalapril maleate and 25 mg hydrochlorothiazide and contain the following inactive ingredients: ferrix oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, pregelatinized starch, purified water, and sodium bicarbonate. Chemical Structure Chemical Structure

Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Red and Iron Oxide Yellow. Each 500 mg tablet contains D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Red #40 Aluminum Lake. Chemical Structure

Etodolac Extended-Release Tablets contain etodolac, which is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water, but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight is 287.37. Its molecular formula is C 17 H 21 NO 3 and it has the following structural formula: The inactive ingredients in etodolac extended-release tablets include: HPMC 2910, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, polydextrose FCC, povidone, titanium dioxide and triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain yellow iron oxide. Meets USP Dissolution Test 4. Chemical Structure

Felbamate Tablets USP, is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate is a white to off-white powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for felbamate tablets USP, 400 mg and 600 mg are croscarmellose sodium, D&C yellow no. 10 lake (600 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized maize starch. Chemical Structure

Felbamate oral suspension, USP is an antiepileptic available as 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for felbamate oral suspension USP, 600 mg/5 mL are carboxymethylcellulose sodium, citric acid monohydrate, FD&C Yellow No. 6, FD&C Red No.40, flavor (cherry), glycerin, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, simethicone emulsion, sorbitol, sucralose and water. Chemical Structure

Fluorouracil Cream is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Cream contains 5% w/w of fluorouracil USP in a cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol and white petrolatum. Chemically, fluorouracil is 5-fluoro-2,4(1 H ,3 H )-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is: Chemical Structure

Fluorouracil Topical Solutions are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Topical Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with edetate disodium, hydroxypropyl cellulose, methylparaben, propylene glycol, propylparaben, purified water and tromethamine. Chemically, fluorouracil is 5-fluoro-2,4(1 H , 3 H )-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is: Chemical Structure

Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below: C 22 H 26 F 3 N 3 OS∙2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains D&C yellow no. 10 aluminum lake (2.5 mg tablet), ferric oxide red (10 mg tablet), ferric oxide yellow (5 mg tablet and 10 mg tablet), FD&C blue no.1 aluminum lake (5 mg tablet), FD&C blue no. 2 aluminum lake (2.5 mg tablet), FD&C yellow no. 6 aluminum lake (2.5 mg tablet and 10 mg tablet), glyceryl mono and di-caprylocaprate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol graft polyethylene glycol copolymer, pregelatinized starch, purified water, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide. Chemical Structure

Fluticasone Propionate Ointment USP, 0.005% contains fluticasone propionate [ S -Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], a synthetic fluorinated corticosteroid, for topical use. Chemically, fluticasone propionate is C 25 H 31 F 3 O 5 S. It has the following structural formula: Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of Fluticasone Propionate Ointment USP, 0.005% contains fluticasone propionate 0.05 mg in a white to off-white translucent ointment base of microcrystalline wax, mineral oil, propylene glycol and sorbitan sesquioleate. Chemical Structure

Glycopyrrolate oral solution is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-bromide. The chemical structure is: The empirical formula for glycopyrrolate oral solution is C 19 H 28 BrNO 3 and the molecular weight is 398.33. The inactive ingredients in glycopyrrolate oral solution are: citric acid, glycerin, sour cherry flavor, ethyl paraben, propylene glycol, propyl paraben, saccharin sodium, sodium citrate, sorbitol solution, and purified water STRUCTURE

Hydrocortisone Butyrate Ointment, Cream and Topical Solution contain the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C 25 H 36 O 6 ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Chemical Structure Hydrocortisone Butyrate Ointment, 0.1% Each gram of hydrocortisone butyrate ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene. Hydrocortisone Butyrate Cream USP, 0.1% Each gram of hydrocortisone butyrate cream contains 1 mg of hydrocortisone butyrate in a hydrophilic base consisting of anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, light mineral oil, propylparaben and butylparaben (preservatives), purified water, sodium citrate anhydrous and white petrolatum. Hydrocortisone Butyrate Topical Solution, 0.1% Each mL of hydrocortisone butyrate topical solution contains 1 mg of hydrocortisone butyrate in a vehicle consisting of citric acid monohydrate, glycerin, isopropyl alcohol (50% v/v), povidone, purified water and sodium citrate.

Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (peach), and 1000 mg (white to off-white) tablets and as a clear to yellowish, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc and additional ingredients listed below: 250 mg tablets: opadry blue 03B20463 (contains FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polyethylene glycol and titanium dioxide) 500 mg tablets: opadry yellow 03B32441 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide) 750 mg tablets: opadry pink 03B34672 (contains hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide) 1000 mg tablets: opadry white Y-1-7000 (contains hypromellose polyethylene glycol and titanium dioxide) Levetiracetam Oral Solution, USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid monohydrate, glycerin, grape flavor, maltitol solution, methylparaben, mono ammonium glycyrrhizinate, propylparaben, purified water, and sodium citrate dihydrate. Meets USP Dissolution Test 2. Chemical Structure

Metronidazole Gel USP, 1% contains metronidazole, USP. It is intended for topical use. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds. Metronidazole is a colorless to slightly yellow gel; each gram contains 10 mg of metronidazole in a base of alcohol (9.3% w/w), edetate disodium, hydroxyethylcellulose, polyethylene glycol 400, propylene glycol, sorbic acid, and purified water. Chemical Structure

Metronidazole Gel USP, 1% contains metronidazole, USP. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole- 1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds. Metronidazole is a colorless to slightly yellow gel; each gram contains 10 mg of metronidazole in a base of alcohol (10% w/w), disodium edetate, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, and purified water. Chemical Structure

Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Chemical Structure

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Use to regrow hair on the top of the scalp (see pictures on side of this carton)

Nortriptyline Hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5 H -dibenzo[ a,d ]cyclohepten-5-ylidene)- N -methyl, hydrochloride. The structural formula is as follows: C 19 H 21 N∙HCl MW = 299.84 Each capsule, for oral administration, contains nortriptyline hydrochloride equivalent to 10 mg, 25 mg, 50 mg, and 75 mg of nortriptyline hydrochloride USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, D&C Yellow #10 (aluminum lake), D&C Yellow #10, FD&C Blue #1 (aluminum lake), FD&C Blue #2 (aluminum lake), FD&C Green #3 (10, 50 and 75 mg only), FD&C Red #40 (aluminum lake), gelatin, I.M.S. 74 OP, magnesium stearate, pregelatinized corn starch, shellac, sodium lauryl sulfate and titanium dioxide. Chemical Structure

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤1% v/v), benzaldehyde, edetate calcium disodium, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, sucrose (49.8% w/v), xanthan gum. Chemical Structure

The active ingredient in ondansetron oral solution, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O∙HCl∙2H 2 O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 5 mL of ondansetron oral solution contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Ondansetron oral solution contains the inactive ingredients citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavor, and sucralose. Chemical Structure

The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O∙HCl∙2H 2 O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4-mg ondansetron tablet for oral administration contains ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet for oral administration contains ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron. Each 24-mg ondansetron tablet for oral administration contains ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients lactose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. In addition, the 4 mg also contains yellow iron oxide and the 24 mg also contains FD&C blue #2 aluminum lake and iron oxide red. Chemical Structure

OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of malathion is (±) - [(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C 10 H 19 O 6 PS 2 , and has the following chemical structure: Chemical Structure

Uses temporary relief of nasal congestion due to the common cold due to hay fever or other upper respiratory allergies associated with sinusitis reduces swelling of nasal passages temporarily restores freer breathing through the nose

WARNING: MAY BE HABIT-FORMING DESCRIPTION The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula: C 12 H 12 N 2 O 3 M.W. = 232.24 Each phenobarbital tablet contains 15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg, 97.2 mg or 100 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Chemical Structure

Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each phenytoin chewable tablet, USP for oral administration, contains 50 mg phenytoin, USP. Also contains: Artificial banana flavor, compressible sugar, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake, hypromellose 2208, lactose monohydrate, magnesium stearate, saccharin sodium, and talc. Chemical Structure

Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 2. Chemical Structure