Active Ingredient (In Each Softgel)
Cetirizine HCl 10 mg
Allergy Relief Capsule, Liquid Filled
FDA Label NDC 69168-392
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Allergy Relief (NDC 69168-392). 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 ingredient (in each softgel), purpose, uses, warnings, ask a doctor before use if you have, ask doctor or pharmacist before use if you are, when using this product, stop use and ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 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 drivinga motor vehicle or operating machinery
Stop Use And Ask Doctor
if an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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 safety seal under cap is broken or missing
Inactive Ingredients
butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink
Questions Or Comments?
Call 1-888-952-0050
Monday through Friday 9AM – 5PM EST
Manufactured For
A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788
Package/Label Principal Display Panel
Cetirizine HCl 10mg Softgels
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