Drug Facts
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride Tablet, Film Coated
FDA Label NDC 69842-834
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 69842-834). 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, purpose, use, 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
Purpose
Nighttime sleep-aid
Use
for relief of occasional sleeplessness
Do Not Use
■ in 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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ 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
■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur
■ 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
■ do not take more than directed
■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
■ children under 12 years: do not use
Other Information
■ each caplet contains: calcium 37 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ protect from moisture
■ use by expiration date on package
Inactive Ingredients
croscarmellose, sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin
Questions Or Comments?
1-800-231-4670
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark
Simply Sleep®.
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 Simply Sleep®*
Nighttime
Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid
• Safe, non-habit forming
• Fall asleep fast, wake up rested
• Does not contain pain reliever
365 MINI-CAPLETS
* Please review the disclaimer below.
