Twin Med - Procure - Cetirizine Hydrochloride Tablets, 10 Mg (55681-302)

Twin Med - Procure - Cetirizine Hydrochloride Tablets, 10 Mg (55681-302)
SPL v3
SPL
SPL Set ID d9437d88-da59-5567-e053-2995a90a362b
Route
ORAL
Published
Effective Date 2022-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose 2208 (100 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 1000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G4 Shape: rectangle Color: white Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2022-03-02
Description

Cetirizine Hydrochloride 10 mg

Purpose

ANTIHISTAMINE

Medication Information

Purpose

ANTIHISTAMINE

Description

Cetirizine Hydrochloride 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 50565-1

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)

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.

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.

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
Directions
adults and children 6 years of age and over

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

Questions?

call toll-free 1-800-935-6737

Other Information
  • store between 20° and 25°C (68° and 77°F)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Active Ingredient (in Each Tablet)

Cetirizine Hydrochloride 10 mg

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 50565-1 (50565-1)

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)

Section 51945-4 (51945-4)

Purpose (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.

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.

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
Directions
adults and children 6 years of age and over

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

Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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

Cetirizine Hydrochloride 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.919176 · Updated: 2026-03-14T23:02:19.584479