Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Sleep Aid Tablet
FDA Label NDC 69168-263
14 label sections · Submitted to the FDA by Allegiant Health · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Sleep Aid (NDC 69168-263). 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, do not use, ask doctor before use if you have, ask doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep aid
Uses
relief of occasional sleeplessness
Do Not Use
- in children under 12 years of age
- with any other products containing diphenhydramine, including ones used on skin
Ask 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 Doctor Or Pharmacist Before Use If You
are taking sedatives or tranquilizers
When Using This Product
- avoid alcoholic beverages
- drowsiness may occur
- do not drive a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
If Pregnancy Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years of age: do not use
Other Information
- store at room temperature store between 20-25°C (68-77°F)
- do not use if blister unit is torn or open
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Package/Label Principal Display Panel
Sleep Aid (263 Health A2z Diphenhydramine HCl 25mg 1)
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