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Acetaminophen PMExtra Strength

Dosage form
TABLET, COATED
Labeler
FOODHOLD U.S.A., LLC
Label updated
2025-09-12
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredients (in each gelcap)

Acetaminophen 500 mg
Diphenhydramine HCl 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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis 
  • liver disease 
  • 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

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

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. 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number 
Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CAREone®

NDC 41520-956-31

Compare to the
active ingredients in
Extra Strength Tylenol ® PM*

Extra Strength 
ACETAMINOPHEN PM

Acetaminophen, 500 mg 
Diphenhydramine HCl, 25 mg 

Pain Reliever 
Nighttime Sleep Aid

Non-habit Forming

80
GELCAPS 

Actual Size 

OUR PHARMACISTS
Rx
RECOMMEND

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Extra Strength Tylenol® PM.
50844    REV0324B55631

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC
SALISBURY, NC 28147
For product questions or concerns,
contact us at 1-833-992-3872
Quality guaranteed or your money back.

[Image in the official label — see DailyMed source]

DailyMed Set ID: fdd7ce80-d6be-41b9-affd-d024cf306b50 · Version 13
NDC: 41520-956