Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Free And Pure Allergy Relief Capsule, Liquid Filled
FDA Label NDC 0363-1175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Free And Pure Allergy Relief (NDC 0363-1175). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, 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: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat
- temporarily relieves these symptoms due to common cold: runny nose, sneezing
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
- adults and children 12 years of age and over - take 1 to 2 softgels
- children 6 to under 12 years of age - take 1 softgel
- children under 6 years of age - do not use
Other Information
- store between 20-25°C (68 to 77°F). Avoid high humidityandexcessive heat.
- Protect from light, heat, humidity
Inactive Ingredients
gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution
Questions Or Comments?
1-800-373-6981
Other
Distributed By:
Walgreen Co.
200 Wilmot Rd., Deerfield, IL 60015
Principal Display Panel
Free & Pure Dye-Free
Allergy Relief
Diphenhydramine HCl 25 mg/Antihistamine
Relieves:
Sneezing
Itchy throat
Runny nose
Itchy, watery eyes
* Please review the disclaimer below.
