Active Ingredient (In Each 30 Ml)
Diphenhydramine HCl 50 mg
Sleep Aid Solution
FDA Label NDC 49035-704
15 label sections · Submitted to the FDA by Wal-mart Stores Inc · 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 Sleep Aid (NDC 49035-704). 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), 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 right away.
Directions
- do not take more than directed
- mL = milliliter
- only use the dose cup provided
- take only one dose per day (24 hours)
- adults and children 12 years and over: 30 mL at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
Other Information
- each 30 mL contains: sodium 21 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, flavors, 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
NDC 49035-704-02
equate™
Compare to
VICKS® ZzzQuil®
Nighttime
Sleep-Aid
active
ingredient*
Nighttime
Sleep-Aid
Diphenhydramine HCl
50 mg per 30 mL
Nighttime Sleep-Aid
• Non-habit forming
• Not for colds or
for pain
• Ages 12+
12 FL OZ (355 mL)
Cherry
Vanilla
F-047
ORG
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA
*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark VICKS® ZzzQuil® Nighttime Sleep-Aid.
50844
ORG052304702
B-047 ORG
Satisfaction guaranteed - Or we’ll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.
Equate 44-047 (Equate 44 047 1)
* Please review the disclaimer below.
