FDA Label for Sleep Aid
View Indications, Usage & Precautions
Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, 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 Caplet)
Diphenhydramine HCl 25mg
Purpose
Night Time Sleep Aid
Uses:
for relief of occasional sleeplessness
Warnings:
Do not use:
■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.
Keep Out Of Reach Of Children
Overdose Warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Directions
■ do not take more than directed(See overdose warning)
■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor
■ children under 12 years: do not use
Other Information
■each caplet contains: calcium 23.52 mg
■store between 15-30°C (59-86°F).
■Avoid high humidity.
■ Protect from light.
Inactive Ingredients
Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.
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