Drug Facts

Active ingredients (in each caplet)                                                                            

Acetaminophen USP 250 mg

Ibuprofen USP 125 mg (NSAID*)

*nonsteroidal anti-in­flammatory drug

Purposes

Pain reliever

Uses

• ­temporarily relieves minor aches and pains due to:­ backachemuscular achesminor pain of arthritisheadachetoothachemenstrual cramps

Warnings

Acetaminophen liver damage warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:­

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:

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:

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.

• with other drugs containing acetaminophen ­
• more than 6 caplets in 24 hours, which is the maximum daily amount for this product ­
• 3 or more alcoholic drinks every day while using this product

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 ­

Ask a doctor before use if

• ­you have liver disease
• stomach bleeding warning applies to you ­
• you have problems or serious side effects from taking pain relievers ­
• you have a history of stomach problems, such as heartburn ­
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ­
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• ­under a doctor’s care for any serious condition­
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product

• ­take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:feel faint ­vomit bloodhave bloody or black stoolshave stomach pain that does not get better
• ­ you have symptoms of heart problems or stroke:­chest pain ­ trouble breathing­weakness in one part or side of body­slurred speech­leg swelling
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
• any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

• ­do not take more than directed ­

Other information

• read all warnings and directions before use.  Keep carton.
• store at 20° to 25°C (68° to 77°F)
• ­avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide