Drug Facts
Active ingredient (in each mini-capsule)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride Capsule
FDA Label NDC 51316-347
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 51316-347). 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, use, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, 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
Use
for relief of occasional sleeplessness
Otc - Do Not Use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
- 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 avoid alcoholic beverages.
Otc - Stop Use
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.
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
- adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
- store in a dry place at 15° – 30°C (59° – 86°F)
- use by expiration date on package
- protect from moisture
Inactive Ingredient
anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.
Questions Or Comments?
1-800-231-4670
Other
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 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-34571
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks Unisom® and SleepMinis®.
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.
Package Label.Principal Display Panel
Compare to the active ingredient in Unisom® SleepMinis®*
Nighttime
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid
Non-habit forming
120 MINI-CAPSULES
* Please review the disclaimer below.
