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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Nighttime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 83059-0122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Nighttime Sleep Aid (NDC 83059-0122). 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, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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
Uses
• for relief of occasional sleeplessness
Warnings
Otc - Do Not Use
Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before useif 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 persist 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 controlled room temperature 20-25°C (68-77°F)
• protect from light, heat and moisture
Inactive Ingredients
FD&C Blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions Or Comments?
1-800-373-6981
Principal Display Panel
Compare to the active ingredient in Unisom® SleepGels
Sleep-Aid
Diphenhydramine HCI Softgels, 50 mg
Label
Label-front (Label Front)
Label-back (Label Back)
* Please review the disclaimer below.
