Active Ingredient (In Each 30 Ml Dose Cup)
Diphenhydramine HCl 50 mg
Nighttime Sleep Aid Solution
FDA Label NDC 49035-330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Nighttime Sleep Aid (NDC 49035-330). 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 30 ml dose cup), 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 relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
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
- mL = milliliter, TBSP = tablespoon; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- take only one dose per day (24 hours)
- adults and children 12 years and over; take 30 mL (2 TBSP) in the dosing cup provided at bedtime if needed or as
directed by a doctor - children under 12 years: do not use
Other Information
- each 30 mL dose cup contains: sodium 17 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum
Questions Or Comments?
1-888-287-1915
Principal Display Panel
equate™
NDC 49035-330-02
Compare to Vicks® ZzzQuil® Nighttime Sleep-Aid Active Ingredient*
Alcohol Free
Nighttime
Sleep Aid
Diphenhydramine HCl 50 mg
Nighttime Sleep Aid
•Non-habit forming
•Not for treating cold or flu
Berry Flavor
12 FL OZ (354 mL)
Satisfaction guaranteed - For questions or comments please call 1-888-287-1915
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716
PRODUCT OF CHINA AND INDIA
*This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® ZzzQuil® Nighttime Sleep-Aid.
50844 ORG101700202
* Please review the disclaimer below.
