Active Ingredients (In Each Tablet)
Cetirizine HCl USP 5 mg
Cetirizine Hydrochloride Tablet
FDA Label NDC 16571-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Cetirizine Hydrochloride (NDC 16571-401). 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 active ingredients (in each tablet), purpose, uses, warnings:, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistimine
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:
Otc - Do Not Use
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
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
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When Using This Product
- 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
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)
Directions
| Adults and children 6 years and over | 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. |
| Adults 65 years and over | 1 tablet once a day; do not take more than 1 tablet in 24 hours. |
| Children under 6 years of age | Ask a doctor |
| Consumers with liver or kidney disease | Ask a doctor |
Other Information
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
Inactive Ingredients
hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Questions?
Call 1-866-562-4597
Other
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Unique Pharmaceutical Labs,
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai, INDIA.
M.L G/1430 Nov. 2016
120004
Cetirizine Hydrochloride Tablets Usp 5 Mg
Rising NDC 16571-401-10
Original Prescription Strength
Cetirizine Hydrochloride
Tablets 5 mg
Antihistamine 24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
100 Tablets
Allergy
Indoor & Outdoor
Allergies
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