Otc - Active Ingredient
Cetirizine HCl 10 mg
Cetirizine Hcl Tablet, Film Coated
FDA Label NDC 57896-992
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Cetirizine Hcl (NDC 57896-992). 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, uses, warnings, otc - 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 - Purpose
Antihistamine
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
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 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.
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
| 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° to 25°C (68° to 77°F).
Inactive Ingredient
hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone,
pregelatinized starch, and titanium dioxide.
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