Acetaminophen, Aspirin, Diphenhydramine citrate
Acetaminophen, Aspirin, Diphenhydramine citrate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Pain Relief PM, PM Headache. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- Acetaminophen, Aspirin, Diphenhydramine citrate
- Brand Names
- Pain Relief PM, PM Headache
- Application Number
- M013
- Sponsor
- CVS Pharmacy
- NDC Codes
- 2
- 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 facial swelling shock 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 take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product 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 stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have difficulty in urination due to enlargement of the prostate gland you have liver disease you have a breathing problem such as emphysema or chronic bronchitis you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have glaucoma you have asthma 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 avoid alcoholic beverages drowsiness may occur 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 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. pain gets worse or lasts for more than 10 days redness or swelling is present 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 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.