Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID e47658af-e0f3-5765-f568-300ba407dc29

Route

ORAL

Published

Effective Date 2017-07-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Levocetirizine (5 mg)

Inactive Ingredients

Cellulose, Microcrystalline Lactose Monohydrate Silicon Dioxide Magnesium Stearate Hypromelloses Titanium Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-09-30

Description

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride USP, 5 mg

Uses

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

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Directions

adults 65 years of age and older	ask a doctor
adults and children 12-64 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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 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

Bottle Label

Bottle Label

Carton Label

Carton Label

Other Information

store between 20° and 25°C (68° and 77°F)
(Bottle only)- Safety Sealed: Do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(Blister only)- Satey Sealed: Do not use if seal is broken or if individual blister unit is open or torn

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-375-3784

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

Stop Use and Ask Doctor If

you have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.

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).

If Pregnant Or Breast Feeding:

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

Active Ingredient (in Each Tablet)

Levocetirizine dihydrochloride USP, 5 mg

Ask A Doctor Before Use If You Have

ever had trouble urinating or emptying your bladder

Structured Label Content

Uses

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

Warnings

Directions

adults 65 years of age and older	ask a doctor
adults and children 12-64 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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 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

Bottle Label

Bottle Label

Carton Label

Carton Label

Other Information (Other information)

store between 20° and 25°C (68° and 77°F)
(Bottle only)- Safety Sealed: Do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(Blister only)- Satey Sealed: Do not use if seal is broken or if individual blister unit is open or torn

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-888-375-3784

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

Stop Use and Ask Doctor If (Stop use and ask doctor if)

you have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.

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).

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Levocetirizine dihydrochloride USP, 5 mg

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": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "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": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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 12-64 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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 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", "Bottle Label": "Bottle Label", "Carton Label": "Carton Label", "Other information": "store between 20° and 25°C (68° and 77°F) (Bottle only)- Safety Sealed: Do not use if carton was opened or if printed foil inner seal on bottle is torn or missing (Blister only)- Satey Sealed: Do not use if seal is broken or if individual blister unit is open or torn", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "Questions or comments?": "Call 1-888-375-3784", "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 ", "Stop use and ask doctor if": "you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away.", "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).", "If pregnant or breast-feeding:": "if breast-feding: not recommended if pregnant: ask a health professional before use", "Active ingredient (in each tablet)": "Levocetirizine dihydrochloride USP, 5 mg", "Ask a doctor before use if you have": "ever had trouble urinating or emptying your bladder"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:18.632267 · Updated: 2026-03-14T23:12:31.383435