Acetaminophen, Aspirin, Diphenhydramine citrate

FDA Drug Profile — Pain Relief PM, PM Headache

Drug Details

Generic Name
Acetaminophen, Aspirin, Diphenhydramine citrate
Brand Names
Pain Relief PM, PM Headache
Application Number
M013
Sponsor
Amerisource Bergen
NDC Codes
3
Dosage Forms
TABLET, FILM 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: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 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 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug 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 glaucoma you have asthma you have difficulty in urination due to enlargement of the prostate gland you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 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 sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer When using this product drowsiness may occur do not drive a motor vehicle or operate machinery avoid alcoholic beverages 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 pain gets worse or lasts for more than 10 days painful area is red or swollen new symptoms occur ringing in the ears or a loss of hearing occurs sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 accidental 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.