acetaminophen

FDA Drug Profile — Aphen, Ringl, Medline, infants fever reducer and pain reliever, good sense pain relief

Drug Details

Generic Name
acetaminophen
Brand Names
Aphen, Ringl, Medline, infants fever reducer and pain reliever, good sense pain relief, topcare infants pain and fever, Pain Relief Childrens, CETAFEN EXTRA, Tylenol 8HR, Infants TYLENOL, infants pain and fever, Robitussin Direct Sore Throat Pain, pain relief, TYLENOL 8 HR MUSCLE ACHES AND PAIN, acetaminophen, MAXIMUM STRENGTH NON-ASPIRIN 250, TYLENOL Extra Strength, pain reliever, PAIN RELIEF, PANADOL Extra Strength, Leader 8HR Arthritis Pain Relief, Uline Acetaminophen Extra Strength, pain relief childrens, childrens acetaminophen, Childrens Tylenol, 8 hr arthritis pain, Non-Aspirin childrens, MAXIMUM STRENGTH NON-ASPIRIN 100
Application Number
M013
Sponsor
Asclemed USA, Inc.
NDC Codes
50
Dosage Forms
TABLET, POWDER, GRANULE, TABLET, EXTENDED RELEASE, TABLET, EFFERVESCENT, SUSPENSION, TABLET, FILM COATED, TABLET, CHEWABLE, TABLET, FILM COATED, EXTENDED RELEASE, TABLET, COATED, KIT
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Uses for the temporary relief of these symptoms associated with menstrual periods: bloating headache muscle aches cramps backache fatigue water-weight gain

Warnings

Warnings 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 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of 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.