Levocetirizine Dihydrochloride Tablets Usp, 5 Mg (otc)

Drug Facts

Composition & Product

Active Ingredients

Levocetirizine (5 mg)

Inactive Ingredients

Lactose Monohydrate Microcrystalline Cellulose Silicon Dioxide Magnesium Stearate Titanium Dioxide Hypromellose 2910 (3 Mpa.s) Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 400 Polysorbate 80

Identifiers & Packaging

Pill Appearance

Imprint: H;LL Shape: oval Color: white Size: 8 mm Score: 2

Marketing Status

ANDA Active Since 2020-10-28

Medication Information

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride USP 5 mg

Use(s)

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Directions

adults 65 years of age and older	ask a doctor
adults and children 12 to 64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6 to 11 years of age	take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Do Not Use

• if you have kidney disease

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Other Information

• store between 20° and 25°C (68° and 77°F)

• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

• safety sealed: do not use if carton was opened or if individual blister unit is open or torn

Active Ingredient(s)

Levocetirizine dihydrochloride USP 5 mg

Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Questions Or Comments?

call 1-888-588-1418.

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel

Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton

Compare to XYZAL^® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label

Compare to XYZAL^® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

•Sneezing

•Runny Nose

•Itchy Nose or Throat

•Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

When Using This Product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast Feeding

if breast-feeding: not recommended
if pregnant: ask a health professional before use

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Stop Use and Ask A doctor If

• you have trouble urinating or emptying your bladder

• an allergic reaction to this product occurs. Seek medical help right away.

Ask A Doctor Before Use If You Have

ever had trouble urinating or emptying your bladder

Structured Label Content

Use(s) (USE(S))

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

adults 65 years of age and older	ask a doctor
adults and children 12 to 64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6 to 11 years of age	take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Do Not Use (DO NOT USE)

• if you have kidney disease

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Other Information (OTHER INFORMATION)

• store between 20° and 25°C (68° and 77°F)

• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

• safety sealed: do not use if carton was opened or if individual blister unit is open or torn

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Levocetirizine dihydrochloride USP 5 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Questions Or Comments? (QUESTIONS or COMMENTS?)

call 1-888-588-1418.

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton

Compare to XYZAL^® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label

Compare to XYZAL^® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

•Sneezing

•Runny Nose

•Itchy Nose or Throat

•Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

When Using This Product (WHEN USING THIS PRODUCT)

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast Feeding (IF PREGNANT OR BREAST-FEEDING)

if breast-feeding: not recommended
if pregnant: ask a health professional before use

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Stop Use and Ask A doctor If (STOP USE AND ASK A DOCTOR IF)

• you have trouble urinating or emptying your bladder

• an allergic reaction to this product occurs. Seek medical help right away.

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

ever had trouble urinating or emptying your bladder

Advanced Ingredient Data

[{"name": "LEVOCETIRIZINE", "unii": "6U5EA9RT2O", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (3 MPA.S)", "unii": "0VUT3PMY82", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat", "PURPOSE": "Antihistamine", "DIRECTIONS": " adults 65 years of age and older ask a doctor adults and children 12 to 64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 11 years of age take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use ", "DO NOT USE": "• if you have kidney disease • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine", "OTHER INFORMATION": "• store between 20° and 25°C (68° and 77°F) • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing • safety sealed: do not use if carton was opened or if individual blister unit is open or torn", "ACTIVE INGREDIENT(S)": "Levocetirizine dihydrochloride USP 5 mg", "INACTIVE INGREDIENTS": "colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.", "QUESTIONS or COMMENTS?": "call 1-888-588-1418. Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA.", "PRINCIPAL DISPLAY PANEL": "Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton Compare to XYZAL ® Allergy 24HR Active Ingredient* Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes Original Prescription Strength 35 TABLETS Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label Compare to XYZAL ® Allergy 24HR Active Ingredient* Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of •Sneezing •Runny Nose •Itchy Nose or Throat •Itchy, Watery Eyes Original Prescription Strength 35 TABLETS", "WHEN USING THIS PRODUCT": " drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "IF PREGNANT OR BREAST-FEEDING": "if breast-feeding: not recommended if pregnant: ask a health professional before use", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "STOP USE AND ASK A DOCTOR IF": "• you have trouble urinating or emptying your bladder • an allergic reaction to this product occurs. Seek medical help right away.", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "ever had trouble urinating or emptying your bladder"}

Levocetirizine Dihydrochloride Tablets Usp, 5 Mg (otc)

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information