FDA Label for Benadryl Allergy
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH TABLET)
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Benadryl Allergy Product Label
The following document was submitted to the FDA by the labeler of this product R J General Corporation. 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.
Drug Facts
Active Ingredient (In Each Tablet)
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
- 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 chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
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 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 |
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
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
Questions Or Comments?
call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)
Active ingredient made in Japan
Distributed by: JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA
©J&JCI 2021
Repackaged & distributed by:
RJ General
2024 Northwest Drive
Cincinnati OH 45231
Principal Display Panel
Benadryl ®
ALLERGY ®
EFFECTIVE ALLERGY RELIEF WHEN YOU NEED IT! ®
Diphenhydramine HCl 25 mg | Antihistamine
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat
30 PACKETS OF 2 TABLETS EACH
* Please review the disclaimer below.