Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 25 mg
Sleep-aid Chewables Tablet, Chewable
FDA Label NDC 69842-958
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 for the product Sleep-aid Chewables (NDC 69842-958). 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 active ingredient (in each chewable tablet), 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
Purpose
Nighttime sleep-aid
Uses
- reduces time to fall asleep if you have difficulty falling asleep
- 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 bronchitis
- 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.
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
- take only one dose per day (24 hours)
- adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate,
mannitol, stearic acid, sucralose, sucrose
Questions Or Comments?
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Compare to the active ingredient in
VICKS® ZzzQuil® Nighttime Sleep-Aid*
Nighttime
Sleep-Aid
Chewables
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid
Non-habit forming tablets
• For restful night's sleep
• Not for treating cold or flu
Grape Flavor
18 CHEWABLE TABLETS
Actual Size
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-11112
CVS® Quality
Money Back Guarantee
DO NOT USE IF INDIVIDUAL BLISTER UNITS ARE BROKEN OR OPEN.
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed
by Procter & Gamble, owner of the registered
trademark VICKS® ZzzQuil® NIGHTTIME
SLEEP-AID.
50844 ORG041868544
* Please review the disclaimer below.
