Active Ingredient (In Each 30 Ml)
Diphenhydramine HCl 50 mg
Night Time Sleep Aid Liquid
FDA Label NDC 55910-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. (dollar General & Rexall) for the product Night Time Sleep Aid (NDC 55910-114). 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 the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- in 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
- 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 serous underling 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)
- mL=milliliter
- keep dosing cup with product
- measure only with dosing cup provided. Do not use any other dosing device
- adults and children 12 years and over
- one dose=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 23 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- protect from light
Inactive Ingredients
citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, sodium citrate
Questions Or Comments?
Call 1-888-309-9030
Principal Display Panel
Compare to the active ingredient of ZzzQUIL®*
Night Time
Sleep Aid
Diphenhydramine HCI 50 mg
Non-habit forming
Not for treating cold or flu
ALCOHOL 10%
Mixed Berry Flavor
fl oz (mL)
Failure to follow these warnings could result in serious consequences.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Procter & Gamble Company. ZzzQUIL® is a registered trademark of the Procter & Gamble Company.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Package Label
DOLLAR GENERAL HEALTH Night time Sleep Aid
* Please review the disclaimer below.
