FDA Label for Topcare Health Nighttime Maximum Strength Sleep Aid
View Indications, Usage & Precautions
Topcare Health Nighttime Maximum Strength Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
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?
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Packaging
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