Levocetirzine Dihydrochloride Tablets Usp, 5 Mg

SPL v3

SPL

SPL Set ID 61fb8bef-d868-adee-3237-d3268d603ba6

Route

ORAL

Published

Effective Date 2018-01-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2020-06-24

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

Other Information

store between 20° and 25°C (68° and 77°F)
(bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(blister only) safety 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.

If Pregnant Or Breast Feeding:

if breast-feding: 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).

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

Levocetirizine Dihydrochloride Tablets Usp, 5 Mg Bottle Label

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets USP, 5 mg

Antihistamine

ALLERGY

24 HOUR

35 Tablets

Levocetirizine Dihydrochloride Tablets, Usp 5 Mg Carton Label

Original Prescription Strength

Levocetirizine

Dihydrochloride

Tablets USP, 5 mg

Antihistamine

ALLERGY

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

35 Tablets

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

Other Information (Other information)

store between 20° and 25°C (68° and 77°F)
(bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(blister only) safety 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.

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

if breast-feding: 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).

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

Levocetirizine Dihydrochloride Tablets Usp, 5 Mg Bottle Label (Levocetirizine Dihydrochloride Tablets USP, 5 mg bottle label)

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets USP, 5 mg

Antihistamine

ALLERGY

24 HOUR

35 Tablets

Levocetirizine Dihydrochloride Tablets, Usp 5 Mg Carton Label (Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label)

Original Prescription Strength

Levocetirizine

Dihydrochloride

Tablets USP, 5 mg

Antihistamine

ALLERGY

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

35 Tablets

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", "Other information": "store between 20° and 25°C (68° and 77°F) (bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing (blister only) safety 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.", "If pregnant or breast-feeding:": "if breast-feding: 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).", "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", "Levocetirizine Dihydrochloride Tablets USP, 5 mg bottle label": "Original Prescription Strength Levocetirizine Dihydrochloride Tablets USP, 5 mg Antihistamine ALLERGY 24 HOUR 35 Tablets", "Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label": "Original Prescription Strength Levocetirizine Dihydrochloride Tablets USP, 5 mg Antihistamine ALLERGY 24 HOUR Relief of: Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes 35 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.820138 · Updated: 2026-03-14T23:11:16.641314