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Drug Facts
Nighttime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 51013-817
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 Nighttime Sleep Aid (NDC 51013-817). 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 softgel), purpose, use, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Use
- for the 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 enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product avoid alcoholic drinks
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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.
Overdosage
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 (50mg) at bedtime if needed, or as directed by a doctor
Other Information
- store at room temperature 15°-30° C (59°-86° F)
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
Principal Display Panel
Nighttime SLEEP-AID 100 Softgels
Diphenhydramine HCl 50mg
compare to active ingredient in Unisom ® SleepGels ® SoftGels
NDC 51013-817-01
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