Cetirizine Hydrochloride Tablets Usp, 10 Mg, Allergy

Cetirizine Hydrochloride Tablets Usp, 10 Mg, Allergy
SPL v8
SPL
SPL Set ID b7a580d5-edfc-41b5-9713-ea18eeb9252e
Route
ORAL
Published
Effective Date 2020-01-18
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 Completed Since 2009-10-01 Until 2019-08-31
Description

Active Ingredients (in each tablet)                                                Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Active Ingredients (in each tablet)                                                Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine

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 Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

 

M. L. G/1430    May 2018

 

120005



Stop Use

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

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.

Ask Doctor

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

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 1-866-562-4597

Other Information

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

Active Ingredients

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

Inactive Ingredients

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

Ask Doctor/pharmacist

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

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.

Cetirizine Hydrochloride
Keep Out of Reach of Children

In case of overdose, get medical help or contact Poison Control Center right away.

If Pregnant Or Breast Feeding:
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

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)

Manufactured by:

Unique Pharmaceutical Labs.

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

Mumbai 400 030, India



Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

 

M. L. G/1430    May 2018

 

120005



Purpose (PURPOSE)

Antihistamine

Stop Use (STOP USE)

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

Warnings (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.

Ask Doctor (ASK DOCTOR)

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

Directions (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? (QUESTIONS?)

Call 1-866-562-4597

Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

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

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.

Cetirizine Hydrochloride
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact 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.

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.839008 · Updated: 2026-03-14T22:55:53.187482