Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate
Drug Details
- Generic Name
- Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate
- Brand Names
- Excedrin PM Triple Action Caplets
- Application Number
- M013
- Sponsor
- Haleon US Holdings LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE
Indications and 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.