FDA Label for Benadryl
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 25 MG CAPSULE BLISTER PACK CARTON LABEL
Benadryl Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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.
Other
Drug Facts
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
- 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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- 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 use this product in children under 6 years of age |
Other Information
- store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
- do not use if carton is open or blister unit is broken
Inactive Ingredients
gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.
Questions Or Comments?
call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)
Principal Display Panel - 25 Mg Capsule Blister Pack Carton Label
Austin/Travis Co. Health & Human Services Dept.
Benadryl
25mg/24
Caps
Date:
Name:
Dr.
USE AS DIRECTED.
1/1/01
123456
Benadryl 25mg/24 CAPS NDC 76413-332-24
Batch: 123456
Lot: 123456
Exp: 1/1/01
Mckneil
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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