Diphenhydramine Hydrochloride Tablet, Coated
FDA Label NDC 57344-091

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aaa Pharmaceutical, Inc. for the product Diphenhydramine Hydrochloride (NDC 57344-091). 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 other, active ingredient (in each caplet), purpose, use, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

When using this product avoid alcoholic drinks

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use

Other Information

  • each caplet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel - 24 Caplet Carton

RESTORE u

NDC 57344-091-01

†COMPARE TO THE
ACTIVE INGREDIENT IN
SIMPLY SLEEP®

Fall Asleep Fast,
Wake Up Refreshed;
Safe and Non-Habit
Forming

Rest Simply
NIGHTTIME SLEEP-AID

Diphenhydramine HCl
Contains No Pain Reliever

24 CAPLETS

* Please review the disclaimer below.