Sleep Aid
FDA Label NDC 73057-358

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ulai Health Llc for the product Sleep Aid (NDC 73057-358). 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 a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

  • helps reduce difficulty falling asleep

Do Not Use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines

Ask A Doctor Before Use If You Have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • avoid alcoholic drinks
  • use caution when driving 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 serious underlying medical illness.

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).

Directions

 adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by your doctor

Other Information

  • each caplet contains: calcium 15 mg
  • store at 20-25oC (68-77oF)

Inactive Ingredients

colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Package Label.Principal Display Panel

PHARBEST

NDC 73057-358-06

Manufactured in the USA

Safe, Non-habit forming

Sleep Aid

*Compare to the active ingredient in Sominex® 

Diphenhydramine HCl 25 mg

Nighttime Sleep Aid

50 CAPLETS

* Please review the disclaimer below.