Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Maximum Strength Nighttime Sleep Aid
FDA Label NDC 51013-179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Maximum Strength Nighttime Sleep Aid (NDC 51013-179). 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 softgel), purpose, use, do not use, ask a doctor before use if you have, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Use
- for relief of occasional sleeplessness
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
- trouble urinating due to an enlarged prostate gland
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
- Store at 15°-30°C (59°-86°F)
- Keep outer carton for complete warnings and product information
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink
Questions Or Comments?
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Principal Display Panel
MARKET BASKET MAXIMUM STRENGTH Nighttime Sleep-Aid
32 SOFTGELS
NDC 51013-179-16
*Compare to the active ingredient in Unisom® SleepGels®
* Please review the disclaimer below.
