Cetirizine Hcl Tablet
FDA Label NDC 70677-1279

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Cetirizine Hcl (NDC 70677-1279). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, keep out of reach of children., dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Keep Out Of Reach Of Children.

→ Dosage & Administration

→ Other Information

→ Inactive Ingredient

→ Other Safety Information

→ Package/label Principal Display Panel

Otc - Active Ingredient

Cetirizine HCl 10 mg

Otc - Purpose

Antihistamine

Indications & Usage

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

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine.

Ask a doctor before use ifyou 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 breastfeeding:

If breastfeeding: 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).

Dosage & Administration

Cetirizine Hydrochloride Tablets, USP 10 mg

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

Other Information

store between 20°C to 25°C (68°F to 77°F)
do not use if imprinted foil inner seal on bottle is broken or missing.
FDA approved organic impurities test procedure differs from USP

Inactive Ingredient

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.