Cetirizine Hydrochloride Tablets

SPL v6

SPL

SPL Set ID e4eca4df-9ad8-b7c4-b512-bfaed5673789

Route

ORAL

Published

Effective Date 2018-12-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Hypromelloses Lactose Monohydrate Magnesium Stearate Polyethylene Glycol 400 Povidone Starch, Corn Titanium Dioxide

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-12-17

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Carton

10 mg carton Labeling

Section 42229-5

Drug Facts

Warnings

Directions

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-888-375-3784.

Bottle Label

Do Not Use If

you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

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 A Doctor If

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.

If Pregnant Or Breast Feeding:

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

Active Ingredient (in Each Tablet)

Cetirizine HCl, 10mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Structured Label Content

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

Carton

10 mg carton Labeling

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antihistamine

Warnings

Directions

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-888-375-3784.

Bottle Label

Do Not Use If (Do not use if)

you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

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 A Doctor If (Stop use and ask a doctor if)

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.

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

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

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

Cetirizine HCl, 10mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 .", "Carton": "10 mg carton Labeling", "42229-5": "Drug Facts", "Purpose": "Antihistamine", "Directions": "adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call 1-888-375-3784 .", "Do not use if": "you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "Other information": "store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.", "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 a doctor if": "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.", "If pregnant or breast-feeding:": "If breast-feeding: not recommended if pregnant: ask a health professional before use.", "Active ingredient (in each tablet)": "Cetirizine HCl, 10mg", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:33.816625 · Updated: 2026-03-14T23:09:23.715399