FDA Label for Nightime Sleep Aid
View Indications, Usage & Precautions
Nightime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Agile Pharmachem. 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
Uses
- For relief of occasional sleeplessness.
Directions
- adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
- children under 12 years:do not use
Warnings
Do not use
- in 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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Other Information
- save carton for full directions and warnings
Inactive Ingredients
Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.
Questions Or Comments
Call 1-855-314-1850
Package Label.Principal Display Panel
DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG
NDC:58805-006-02
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