Active Ingredient (In Each Chewable Gel)
Diphenhydramine HCl 25 mg
Sleep-aid Chewable Gel
FDA Label NDC 79903-426
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. (see Also Equate) for the product Sleep-aid (NDC 79903-426). 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
- reduce 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 serious underlying medical illness
If Pregnant Of 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 chewable gel per day (24 hours)
| adults and children 12 years and over | take 2 chewable gel at bedtime if needed or directed by a doctor |
| children under 12 years | do not use |
Other Information
- store between 20-25°C (68° to 77°F). Do not refrigerate
- protect from light
Inactive Ingredients
Alcohol, anhydrous citric acid, corn syrup, FD&C blue #1, FD&C red #40, glycerin, maltodextrin, medium-chain triglycerides, natural and artifical flavors, pectin, propylene glycol, purified water, sucralose, sucrose, trisodium citrate dihydrate
Questions Or Comments?
Call 1-888-287-1915
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*Compare to Vicks® ZzzQuil™ LiquiCaps™ active ingredient*
NIGHTTIME
Sleep-Aid
Diphenhydramine HCl 25 mg
Nighjttime sleep-aid
- Relief of occasional sleeplessness
- Helps to reduce difficulty falling asleep
*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: Walmart Inc.,
Bentonville, AR 72716
Product Label
EQUATE Nighttime Sleep-Aid
* Please review the disclaimer below.
