Cetirizine Hydrochloride Tablets, 10 Mg, Allergy

Cetirizine Hydrochloride Tablets, 10 Mg, Allergy
SPL v5
SPL
SPL Set ID 4913192a-7364-3f19-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2019-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Starch, Corn Polyethylene Glycol Povidone Titanium Dioxide Hypromelloses Lactose Magnesium Stearate

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

Medication Information

Description

Active Ingredients (in each tablet)                                                        Purpose Cetirizine HCl 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 for PACK Pharmaceuticals, LLC

Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this 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

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

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose

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

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 Poison Control Center right away.

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 for PACK Pharmaceuticals, LLC

Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this 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)

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

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose

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

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 Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.281936 · Updated: 2026-03-14T23:03:17.077951