Acetaminophen 250 mg and Ibuprofen 125 mg Acetaminophen 250 mg and Ibuprofen 125 mg Tablets POVIDONE POLYETHYLENE GLYCOL, UNSPECIFIED LACTOSE MONOHYDRATE STARCH, CORN CROSCARMELLOSE SODIUM GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN IBUPROFEN IBUPROFEN T;II
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 51672-4258-1 Acetaminophen 250 mg and Ibuprofen 125 mg 216 Tablets Carton Label
- PRINCIPAL DISPLAY PANEL NDC 51672-4258-1 Acetaminophen 250 mg and Ibuprofen 125 mg 216 Tablets Carton Label
Overview
Uses • temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
Indications & Usage
Uses • temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
Dosage & Administration
Directions • do not take more than directed adults and children 12 years and over • take 2 tablets every 8 hours while symptoms persist children under 12 years • ask a doctor • do not take more than 6 tablets in 24 hours, unless directed by a doctor
Warnings & Precautions
Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 tablets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Purpose
Purposes Pain reliever Pain reliever
Do Not Use
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 acetaminophen or any other pain reliever • right before or after heart surgery
When Using
When using this product • take with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better • you have symptoms of heart problems or stroke: o chest pain o trouble breathing o weakness in one part or side of body o slurred speech o leg swelling • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area • any new symptoms appear
Keep Out of Reach of Children
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.
Storage & Handling
Other information • read all warnings and directions before use. Keep carton. • store at 20 to 25ºC (68 to 77ºF) • avoid excessive heat above 40°C (104°F)
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