FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Softech Pharma Pvt. Ltd. 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 25 mg
Purpose
Nighttime sleep-aid
Uses
- for relief of occassional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products
Directions
Take only one dose per day (24 hours) - see Overdose warning
adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor
Other Information
- store at 20-25˚C (68-77˚F)
- avoid excessive heat above 40˚C (104˚F) and high humidity
- protect from light
Inactive Ingredients
FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide
Principal Display Panel
Diphenhydramine Hydrochloride Capsules, USP 25 mg
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