Drug Facts
Active ingredient (in each banded capsule)
Diphenhydramine HCI 25 mg
Diphenhydramine Hydrochloride Capsule
FDA Label NDC 51316-835
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 Hydrochloride (NDC 51316-835). 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 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
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 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.
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 to 2 capsules |
| children 6 to under 12 years of age | 1 capsule |
| children under 6 years of age | do not use this product in
children under 6 years of age |
Other Information
store in a dry place at 15° – 30°C (59° – 86°F)
protect from moisture
Inactive Ingredient
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Otc - Questions
Questions or comments? 1-800-231-4670
Other
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-34601
Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
Package Label.Principal Display Panel
Compare to the active ingredient in Benadryl®*
Allergy Relief
DIPHENHYDRAMINE HYDROCHLORIDE
25 mg - Antihistamine
Relief of: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat
100 CAPSULES
* Please review the disclaimer below.
