Otc - Active Ingredient
Cetirizine HCl 10 mg
Cetirizine Hydrochloride Tablet
FDA Label NDC 70692-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc for the product Cetirizine Hydrochloride (NDC 70692-139). 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, inactive ingredient, dosage & administration, warnings, otc - keep out of reach of children, otc - purpose, other safety information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Dosage & Administration
- adults & 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: Ask a doctor
- consumers with liver or kidney disease: Ask a doctor
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 sedatives or tranquilizers.
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, ask a health professional before use.
Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Otc - Purpose
Antihistamine
Other Safety Information
■ store at room temperature between 20-25°C (68-77°F).
■ close cap tightly after use.
■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye).
TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing.
Package Label.Principal Display Panel
Label (Label)
Carton (Carton)
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