FDA Label for Allergy Dyefree
View Indications, Usage & Precautions
Allergy Dyefree Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Diphenhydramine HCl 25 mg
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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