Active Ingredient(S)
Diphenhydramine HCl 25 mg
Allergy Dyefree Capsule, Liquid Filled
FDA Label NDC 69168-409
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 Dyefree (NDC 69168-409). 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(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use(S)
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
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
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
- 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
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
Pregnancy/Breastfeeding
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 (1-800-222-1222) right away.
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
Adults and children 12 years and over: 1 to 2 softgels
Children 6 to under 12 years: 1 softgel
Children under 6 years: do not use this product in children under 6 years of age
Other Information
- do not use if blister is torn or broken
Storage
- store between 20-25 °C (68-77 °F).
- Avoid high humidity and excessive heat. Protect from light.
Inactive Ingredients
gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink
Questions
Call 1-888-952-0050
Monday through Friday 9AM - 5PM EST
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Diphenhydramine HCl 25mg (409 Allergy Dye Free 1)
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