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Excedrin PM Triple Action Caplets

acetaminophen, aspirin (nsaid) and diphenhydramine citrate · Excedrin PM Triple Action Caplets is a nonsteroidal anti-inflammatory drug (over-the-counter) containing acetaminophen, aspirin (nsaid) and diphenhydramine citrate, made by Haleon US Holdings LLC.

Type
Over the counter
Drug class
Nonsteroidal Anti-inflammatory Drug
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
acetaminophen, aspirin (nsaid) and diphenhydramine citrate
Active ingredients
Acetaminophen, Aspirin, Diphenhydramine Citrate
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet, coated
Label holder
Haleon US Holdings LLC
FDA application
M013
Label updated
03/14/2024

Active ingredients

(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever Pain Reliever Nighttime sleep-aid

Uses

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

Directions

  • Do not use more than directed
  • Do not use in children under 12 years of age
  • Adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
  • Do not take more than 2 caplets in 24 hours, unless directed by a doctor

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include:
  • Hives
  • Facial swelling
  • Asthma (wheezing)
  • Shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • More than 2 caplets in 24 hours, which is the maximum daily amount
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • Are age 60 or older
  • Have had stomach ulcers or bleeding problems
  • Take a blood thinning (anticoagulant) or steroid drug
  • Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • Have 3 or more alcoholic drinks every day while using this product
  • Take more or for a longer time than directed Do not use
  • If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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
  • In children under 12 years of age Ask a doctor before use if
  • You have liver disease
  • Stomach bleeding warning applies to you
  • You have a history of stomach problems, such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic
  • You have asthma
  • You have glaucoma
  • You have a breathing problem such as emphysema or chronic bronchitis
  • You have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking
  • A prescription drug for:
  • Diabetes
  • Gout
  • Arthritis
  • Any other drug, or are under a doctor’s care for any serious condition
  • Any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
  • Sedatives or tranquilizers When using this product
  • Drowsiness will occur
  • Avoid alcoholic drinks
  • Do not drive a motor vehicle or operate machinery Stop use and ask a doctor if
  • An allergic reaction occurs. Seek medical help right away.
  • You experience any of the following signs of stomach bleeding:
  • Feel faint
  • Vomit blood
  • Have bloody or black stools
  • Have stomach pain that does not get better
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • Pain gets worse or last for more than 10 days
  • Painful area is red or swollen
  • Ringing in the ears or a loss of hearing occurs
  • Any new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

  • If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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
  • In children under 12 years of age

Ask a doctor before use

If

  • You have liver disease
  • Stomach bleeding warning applies to you
  • You have a history of stomach problems, such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic
  • You have asthma
  • You have glaucoma
  • You have a breathing problem such as emphysema or chronic bronchitis
  • You have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use

Taking

  • A prescription drug for:
  • Diabetes
  • Gout
  • Arthritis
  • Any other drug, or are under a doctor’s care for any serious condition
  • Any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
  • Sedatives or tranquilizers

When using this product

  • Drowsiness will occur
  • Avoid alcoholic drinks
  • Do not drive a motor vehicle or operate machinery

Stop use and ask a doctor

  • An allergic reaction occurs. Seek medical help right away.
  • You experience any of the following signs of stomach bleeding:
  • Feel faint
  • Vomit blood
  • Have bloody or black stools
  • Have stomach pain that does not get better
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • Pain gets worse or last for more than 10 days
  • Painful area is red or swollen
  • Ringing in the ears or a loss of hearing occurs
  • Any new symptoms occur These could be signs of a serious condition

Pregnancy or breastfeeding

Ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive ingredients

Benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate

Questions?

1-800-468-7746

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet, coated250 mg / 250 mg / 38 mgoral1

Manufacturers and labels

1 FDA label

  • Haleon US Holdings LLCShown hereM013 · Label 03/14/2024 · NDC 0067-2056Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Excedrin PM Triple Action Caplets: common questions

What is Excedrin PM Triple Action Caplets used for?
• for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Is Excedrin PM Triple Action Caplets a prescription drug?
No. Excedrin PM Triple Action Caplets is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Excedrin PM Triple Action Caplets?
Yes. Other FDA-listed products with the same active ingredients include Pain Relief PM.
Who makes Excedrin PM Triple Action Caplets?
Haleon US Holdings LLC lists Excedrin PM Triple Action Caplets with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/14/2024 · Label text is shown as published by the manufacturer. Not medical advice