Acetaminophen And Diphenhydramine Hydrochloride Tablet
FDA Label NDC 79903-267

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Acetaminophen And Diphenhydramine Hydrochloride (NDC 79903-267). 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 drug facts, purpose, uses, warnings, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age

Ask A Doctor Before Use If You Have

  • liver disease.
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product

  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours.
    • children under 12 years: do not use

Other Information

  • avoid high humidity
  • store at 20° to 25°C (68° to 77°F)
  • use by expiration date on package

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions Or Comments?

call 1-888-287-1915 (Monday-Friday 8:30 AM to 5:00 PM EST)

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRODUCT OF INDIA

Package Label-Principal Display Panel 500 Mg/25 Mg (80 Gelcaps Bottle)

equate™

NDC 79903-267-80

Compare to
Extra Strength
Tylenol® PM
    active
ingredients*

EXTRA STRENGTH

Pain Reliever PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep-Aid
Non-habit forming

Actual Size

80
GELCAPS



Package Label-principal Display Panel 100 Caplets (Aurophen Fig1)

Package Label-principal Display Panel 100 Caplets (Aurophen Fig1)

* Please review the disclaimer below.