Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25 mg
Allergy Relief
FDA Label NDC 55319-609
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Allergy Relief (NDC 55319-609). 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 capsule), 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 hay fever or other upper respiratory allergies: sneezing, runny nose
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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
- swallow whole; do not crush, chew or dissolve
- 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, povidone, propylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide
Questions Or Comments?
Call 1-888-287-1915
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MIDWOOD BRANDS, LLC
500 Volvo Pkwy
Chesapeake, VA 23320 USA
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