Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Topcare Health Nighttime Maximum Strength Sleep Aid Capsule, Liquid Filled
FDA Label NDC 76162-438
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Health Nighttime Maximum Strength Sleep Aid (NDC 76162-438). 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, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
Warnings
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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product avoid alcoholic drinks
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.
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.
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)
Inactive Ingredients
FD&C blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide
Questions?
Call toll-free: 1-888-423-0139
Packaging
Nighttime Maximum Strength (76162438 2)
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