FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- 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,
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. 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 banded capsule)
Diphenhydramine HCI 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.
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
- 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch
Questions Or Comments?
1-800-231-4670
Other
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.
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Benadryl®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34601
Package Label.Principal Display Panel
CVSHealth
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.