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Drug Facts
Nighttime Sleep Aid Liquid
FDA Label NDC 68163-730
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Nighttime Sleep Aid (NDC 68163-730). 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 other, active ingredient (in each 30 ml dose cup), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 30 Ml Dose Cup)
Diphenhydramine HCl 50 mg
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
▪ 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.
When Using This Product
▪ avoid alcoholic beverages
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ take only one dose per day (24 hours)▪ only use cup provided
adults & children 12yrs & over | 30 mL at bed time if needed or as directed by a doctor |
Children under 12 yrs | do not use |
Other Information
▪ each 30 mL dose contains: potassium 5 mg, sodium 10 mg▪ store at room temperature
Inactive Ingredients
anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Principal Display Panel
DRx CHOICE®
NDC 68163-730-06
Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid*
Sleep-Aid
Nighttime
DIPHENHYDRAMINE HCl
Non-Habit Forming
BERRY FLAVOR
Naturally and Artificially Flavored
Not for Pain. Not for Colds Just for Sleep.
6 FL OZ (177 mL)
$1.99 AMAZING NEW VALUE!
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
Sleep Aid Nighttime Berry Flavor Diphenhydramine HCl (Image 01)
* Please review the disclaimer below.
