Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25mg
Sleep Aid Tablet
FDA Label NDC 84324-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Sleep Aid (NDC 84324-016). 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 caplet), purpose, uses:, warnings:, 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
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.
Questions Or Comments?
Call 1 (718) 337-8733 or visit [email protected]
* Please review the disclaimer below.
