Otc - Active Ingredient Section
Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine
Cetirizine Hydrochloride
FDA Label NDC 61919-538
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Direct_rx for the product Cetirizine Hydrochloride (NDC 61919-538). 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 section, otc - purpose section, warnings section, otc - ask doctor section, otc - ask doctor/pharmacist section, otc - when using section, indications & usage section, otc - stop use section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose Section
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 Section
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.
Otc - Ask Doctor Section
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist Section
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Otc - When Using Section
- drowsines may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinary
Indications & Usage Section
drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.
Otc - Stop Use Section
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding Section
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
In case of overdose, get medical help or contact Poison Control Center right away.
Instructions For Use Section
| 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 |
Dosage & Administration Section
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
Other Safety Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredient Section
Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Otc - Questions Section
Call 1-866-562-4597
Other
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
Package Label.Principal Display Panel
Image Description (Cetirizine538)
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