Active Ingredient (In Each Chewable Gel)
Diphenhydramine HCl 25 mg
Sleep Aid Chewable Gel
FDA Label NDC 0363-9236
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Sleep Aid (NDC 0363-9236). 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 gel), 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
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- a breathing problem such as 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
- 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
- take only one dose per day (24 hours)
| adults and children 12 years and over | take 2 chewable gels at bedtime if needed or directed by a doctor |
| children under 12 years | do not use |
Other Information
- store between 20-25°C (68-77°F). Do not refrigerate
- protect from light
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Inactive Ingredients
Alcohol, anhydrous citric acid, corn syrup, FD&C Blue #1, FD&C Red #40, glycerin, maltodextrin, medium-chain triglycerides, natural and artificial flavors, pectin, propylene glycol, purified water, sucralose, sucrose, trisodium citrate dihydrate
Principal Display Panel
Compare to the active ingredient in Vicks® ZzzQuil™ LiquiCaps™††
Sleep
Aid
DIPHENHYDRAMINE HCl25 mg
NIGHTTIME SLEEP AID
Nighttime
- Relief of occasional sleeplessness, helps to reduce difficulty falling asleep
Natural Grape flavor (with other natural flavors)
SOLID CHEWABLE GELS
This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® ZzzQuil™ LiquiCaps™ are trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
Product Label
WALGREENS Sleep Aid
* Please review the disclaimer below.
