Cetirizine Hydrochloride Tablets Usp, 10 Mg, Allergy

SPL v9

SPL

SPL Set ID 4b192084-dfdc-47bc-a968-6f49e137b248

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Starch, Corn Polyethylene Glycol, Unspecified Povidone, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2009-10-01

Description

Active Ingredient (in each tablet) Cetirizine HCl USP 10 mg

Purpose

Antihistamine

How Supplied

NDC: 71335-0300-1: 30 Tablets in a BOTTLE NDC: 71335-0300-2: 14 Tablets in a BOTTLE NDC: 71335-0300-3: 7 Tablets in a BOTTLE NDC: 71335-0300-4: 10 Tablets in a BOTTLE NDC: 71335-0300-5: 15 Tablets in a BOTTLE NDC: 71335-0300-6: 90 Tablets in a BOTTLE NDC: 71335-0300-7: 20 Tablets in a BOTTLE NDC: 71335-0300-8: 60 Tablets in a BOTTLE NDC: 71335-0300-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

NDC: 71335-0300-1: 30 Tablets in a BOTTLE

NDC: 71335-0300-2: 14 Tablets in a BOTTLE

NDC: 71335-0300-3: 7 Tablets in a BOTTLE

NDC: 71335-0300-4: 10 Tablets in a BOTTLE

NDC: 71335-0300-5: 15 Tablets in a BOTTLE

NDC: 71335-0300-6: 90 Tablets in a BOTTLE

NDC: 71335-0300-7: 20 Tablets in a BOTTLE

NDC: 71335-0300-8: 60 Tablets in a BOTTLE

NDC: 71335-0300-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Active Ingredient (in each tablet) 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

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

M. L. G/1430 Jul. 2020

126406

Section 50566-9

Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 51945-4

Cetirizine Hydrochloride 10 mg Tablet

Section 55106-9

Active Ingredient (in each tablet)

Cetirizine HCl USP 10 mg

Warnings:

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.

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 1-844-874-7464

Other Information:

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

When Using This Product

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

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)

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

Section 42229-5 (42229-5)

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

M. L. G/1430 Jul. 2020

126406

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 51945-4 (51945-4)

Cetirizine Hydrochloride 10 mg Tablet

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

Cetirizine HCl USP 10 mg

Purpose

Antihistamine

Warnings:

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.

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 1-844-874-7464

How Supplied (HOW SUPPLIED)

NDC: 71335-0300-1: 30 Tablets in a BOTTLE

NDC: 71335-0300-2: 14 Tablets in a BOTTLE

NDC: 71335-0300-3: 7 Tablets in a BOTTLE

NDC: 71335-0300-4: 10 Tablets in a BOTTLE

NDC: 71335-0300-5: 15 Tablets in a BOTTLE

NDC: 71335-0300-6: 90 Tablets in a BOTTLE

NDC: 71335-0300-7: 20 Tablets in a BOTTLE

NDC: 71335-0300-8: 60 Tablets in a BOTTLE

NDC: 71335-0300-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information:

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

When Using This Product (When using this product)

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

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)

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "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": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "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", "42229-5": "Manufactured by: Unique Pharmaceutical Labs. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 M. L. G/1430 Jul. 2020 126406", "50566-9": "Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "51945-4": "Cetirizine Hydrochloride 10 mg Tablet", "55106-9": "Active Ingredient (in each tablet) Cetirizine HCl USP 10 mg", "Purpose": "Antihistamine", "Warnings:": "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.", "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 1-844-874-7464", "HOW SUPPLIED": "NDC: 71335-0300-1: 30 Tablets in a BOTTLE NDC: 71335-0300-2: 14 Tablets in a BOTTLE NDC: 71335-0300-3: 7 Tablets in a BOTTLE NDC: 71335-0300-4: 10 Tablets in a BOTTLE NDC: 71335-0300-5: 15 Tablets in a BOTTLE NDC: 71335-0300-6: 90 Tablets in a BOTTLE NDC: 71335-0300-7: 20 Tablets in a BOTTLE NDC: 71335-0300-8: 60 Tablets in a BOTTLE NDC: 71335-0300-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other Information:": "store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].", "Inactive ingredients": "Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.", "When using this product": "drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary.", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:20.505377 · Updated: 2026-03-14T23:03:21.577672