Benadryl Allergy
Benadryl Allergy
7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549
HUMAN OTC DRUG LABEL
Sep 3, 2025
JC World Bell Wholesale Co., Inc.
DUNS: 805257581
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPHENHYDRAMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Labeling:
INDICATIONS & USAGE SECTION
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 common cold:
- runny nose
- sneezing
SPL UNCLASSIFIED SECTION
Other information
***each tablet contains:**calcium 15 mg
- store between 20-25°C (68°-77°F). Protect from light. *do not use if pouch is torn or damaged
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Diphenydramine HCl 25mg
Purpose
Antihistamine
WARNINGS SECTION
Warnings
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 bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilzers
When using this product
- marked drawsiness 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, espesially 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)
DOSAGE & ADMINISTRATION SECTION
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
adults and children 12 years and over |
1 to 2 tablets |
children 6 to under 12 years |
1 tablet |
children under 6 years |
do not use |
INACTIVE INGREDIENT SECTION
Inactive ingredients
carnauba wax, croscarmellose sodium, D&C red no.27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
call1-877-717-2824(toll-free)or 215-273-8755(collect)