Drug Facts
Active ingredient (in each caplet)
Diphenhydramine HCl 50 mg
Diphenhydramine Hcl Tablet, Coated
FDA Label NDC 51316-221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Diphenhydramine Hcl (NDC 51316-221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Uses
temporarily relives 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 relives these symptoms due to the common cold:
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - When Using
When using this product
- marked drowsiness mau 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 brest-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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, or as directed by a doctor
do not take more than 6 doses in 24 hours
| adults and children 12 years of age and over | 1 caplet |
| children under 12 years of age | do not use |
Other Information
- store in a dry place at 15° - 30° C (59° - 86° F).
- ptotect from moisture
Inactive Ingredient
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin.
Otc - Questions
1-800-231-4670
Other
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS
Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
V-34601
TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN.
RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION.
* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.
Package Label.Principal Display Panel
Compare to the active ingredient in Benadryl® Allergy Extra Strength*
Extra Strength
Allergy Relief
Diphenhydramine HCl, 50mg
Antihistamine
Temporatry relief of
Sneezing
Itchy throat
Runny nose
Itchy, watery eyes
24 Caplets
* Please review the disclaimer below.
