FDA Label for Allergy
View Indications, Usage & Precautions
Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. 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 (In Each Capsule)
Diphenhydramine HCl 25 mg
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• temporarily relieves these symptoms due to the common cold:• runny nose• sneezing
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, or as directed by a doctor• do not take more than 6 doses in 24 hours
adults and children 12 years and over | 1 to 2 capsules |
children 6 to under 12 years | 1 capsule |
children under 6 years | do not |
Other Information
• store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.• each capsule is sealed with a Uni Band® seal which bonds the two capsule halves together. Do not use if seal is broken or missing. Do not use if blister unit is broken or torn.
Inactive Ingredients
anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate
Principal Display Panel
allergy capsules
DIPHENHYDRAMINE HCI 25mg
ANTIHISTAMINE
For the temporary relief of:
itchy, watery eyes
runny nose
sneezing due to colds & allergies
ACTUAL SIZE
EASY TO SWALLOW
24 CAPSULES
Compare to Active Ingredient in Benadryl® Allergy
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