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Acetaminophen and Diphenhydramine hydrochloride

Dosage form
TABLET
Labeler
WALMART INC.
Label updated
2024-07-03
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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 20º to 25°C (68º 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



[Image in the official label — see DailyMed source]

DailyMed Set ID: 16d5786c-2346-f970-e063-6394a90a0a8c · Version 2
NDC: 79903-267