View Drug - Excedrin PM Triple Action Caplets
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Excedrin PM Triple Action Caplets

Generic: ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE

100%
Basic Information
Manufacturer
Haleon US Holdings LLC
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
b3812d27-40af-40d7-864a-dfa4ae34cb9e
Purpose
Purposes Pain Reliever Pain Reliever Nighttime sleep-aid
Indications & Usage
Uses • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
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.