Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 296e5977-0e8c-4147-a94d-374eb913ab51

Route

ORAL

Published

Effective Date 2012-01-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Povidone Lactose Monohydrate Magnesium Stearate Starch, Corn Talc Titanium Dioxide Polyethylene Glycols Hypromelloses

Identifiers & Packaging

Pill Appearance

Imprint: RI52 Shape: rectangle Color: white Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2007-12-27

Description

Cetirizine HCl, USP 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl, USP 10 mg

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

Section 42229-5

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Directions

a dults 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.

a dults 65 years and over: ask a doctor

c hildren under 6 years of age: ask a doctor

c onsumers with liver or kidney disease: ask a doctor

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.

Questions?

call 1-800-406-7984

Other Information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
store between 20° to 25° C (68° to 77° F)

Inactive Ingredients

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

Principal Display Panel

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.

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).

Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Structured Label Content

Uses (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

Section 42229-5 (42229-5)

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

a dults 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.

a dults 65 years and over: ask a doctor

c hildren under 6 years of age: ask a doctor

c onsumers with liver or kidney disease: ask a doctor

Do Not Use (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.

Questions? (QUESTIONS?)

call 1-800-406-7984

Other Information (OTHER INFORMATION)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
store between 20° to 25° C (68° to 77° F)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

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).

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Cetirizine HCl, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

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": "POVIDONE", "unii": "FZ989GH94E", "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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "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", "42229-5": "KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320", "PURPOSE": "Antihistamine", "DIRECTIONS": "a dults 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. a dults 65 years and over: ask a doctor c hildren under 6 years of age: ask a doctor c onsumers with liver or kidney disease: ask a doctor", "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.", "QUESTIONS?": "call 1-800-406-7984", "OTHER INFORMATION": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) store between 20° to 25° C (68° to 77° F)", "INACTIVE INGREDIENTS": "corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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.", "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).", "ACTIVE INGREDIENT (IN EACH TABLET)": "Cetirizine HCl, USP 10 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:26.502898 · Updated: 2026-03-14T22:53:04.035717