Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NuLev ® Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side. Bottles of 100 tablets NDC 68220-118-10 Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY. For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX). Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. NULEV is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. © 2025 Viatris Inc. Rev. 7/2025 201093-01 VS:SOV:NULE:R1; Principal Display Panel – 0.125 mg NDC 68220- 118 -10 NuLev ® Chewable Melt Tablets (hyoscyamine sulfate tablets, USP) 0.125 mg/tablet Rx only 100 tablets Each chewable melt tablet contains: Hyoscyamine Sulfate USP 0.125 mg. Dosage: See package insert for complete prescribing information. PHARMACISTS: Dispense in tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. Avoid exposure to heat. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. NULEV is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. © 2025 Viatris Inc. VSSOV118A1 200956-01 Rev. 7/2025 NuLev Chewable Melt Tablets 0.125 mg Label
- HOW SUPPLIED NuLev ® Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side. Bottles of 100 tablets NDC 68220-118-10 Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY. For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX). Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. NULEV is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. © 2025 Viatris Inc. Rev. 7/2025 201093-01 VS:SOV:NULE:R1
- Principal Display Panel – 0.125 mg NDC 68220- 118 -10 NuLev ® Chewable Melt Tablets (hyoscyamine sulfate tablets, USP) 0.125 mg/tablet Rx only 100 tablets Each chewable melt tablet contains: Hyoscyamine Sulfate USP 0.125 mg. Dosage: See package insert for complete prescribing information. PHARMACISTS: Dispense in tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. Avoid exposure to heat. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. NULEV is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. © 2025 Viatris Inc. VSSOV118A1 200956-01 Rev. 7/2025 NuLev Chewable Melt Tablets 0.125 mg Label
Overview
Each round, white, peppermint flavored tablet can be chewed or placed on tongue for disintegration and contains 0.125 mg of hyoscyamine sulfate USP. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: Inactive ingredients include: lactose monohydrate, magnesium stearate, mannitol USP, peppermint flavor, starch, stearic acid. Chemical Structure
Indications & Usage
NuLev ® is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). NuLev ® is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
Dosage & Administration
Dosage may be adjusted according to the conditions and severity of symptoms. NuLev ® Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) may be chewed or placed on tongue and allowed to disintegrate. Tablets may be taken with or without water. Adults and pediatric patients 12 years of age and older 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
Warnings & Precautions
WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, NuLev ® may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Contraindications
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis): paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
Adverse Reactions
All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.
Drug Interactions
Additive adverse effects resulting from cholinergic blockade may occur when NuLev ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of hyoscyamine sulfate. Administer NuLev ® before meals; antacids after meals.
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