Drug Facts
Active Ingredient (in each mini-capsule)
Diphenhydramine HCl 25mg
Diphenhydramine Hcl Capsule
FDA Label NDC 69842-537
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 69842-537). 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, 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Nighttime sleep-aid
Uses
for relief of occasional sleeplessness
Do Not Use
- for children under 12 years of age
- 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 brochitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic beverages
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdosage
In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children 12 years and over: take 2 mini-capsules (50mg) at bedtime if nedded, or as directed by a doctor
Other Information
- Store at 25°C(77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- protect from moisture
Inactive Ingredient
citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide
Question Or Comments?
1-800-231-4670
Other
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE
BAND AROUND CAPSULE IS BROKEN OR MISSING
*This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34571
Package Label.Principal Display Panel
CVSHealth
Compare to the active ingredient in Unisom® SleepMinis™*
Nighttime Sleep-Aid
Diphenhydramine HCl, 25mg
Nighttime sleep-aid
Non-habit forming
60 Mini-Capsules
* Please review the disclaimer below.
