Active Ingredient (In Each 30 Ml Dose Cup)
Diphenhydramine HCl 50 mg
Nighttime Sleep Aid Solution
FDA Label NDC 50844-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Nighttime Sleep Aid (NDC 50844-200). 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?
1-800-426-9391
Principal Display Panel
Quality
Plus
NDC 50844-200-45
Compare to active ingredient in
VICKS® ZzzQuil® Nighttime
Sleep-Aid*
Nighttime
Sleep Aid
Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID
• Non-habit forming
• Not for treating Cold or Flu
Berry Flavor
6 FL OZ (177 mL)
ALCOHOL FREE
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark VICKS® ZzzQuil®
Nighttime Sleep-Aid. 50844 ORG101700245
Distributed by:
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
44-002a (Quality Plus 44 002a 1)
* Please review the disclaimer below.
