Acetaminophen and Ibuprofen

Acetaminophen and Ibuprofen Acetaminophen and Ibuprofen CARNAUBA WAX SILICON DIOXIDE CROSPOVIDONE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE IBUPROFEN IBUPROFEN ACETAMINOPHEN ACETAMINOPHEN AI

Active ingredients (in each caplet) Acetaminophen, USP 250 mg Ibuprofen, USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purposes Pain reliever Pain reliever

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis

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 caplets 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. 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 blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days redness or swelling is present in the painful area any new symptoms appear 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. 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.

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 blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days redness or swelling is present in the painful area any new symptoms appear

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.

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 adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

<table width="100%"><caption/><tbody><tr><td>adults and children 12 years and over</td><td>&#x25A0; <content styleCode="bold">take 2 caplets every 8 hours</content>while symptoms persist </td></tr><tr><td>children under 12 years</td><td>&#x25A0; ask a doctor</td></tr></tbody></table>

Other information each caplet contains: sodium 3 mg read all warnings and directions before use. store at 20°C to 25°C (68°F to 77°F) avoid excessive heat above 40°C (104°F)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide

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*** This product is not manufactured or distributed by the owners of Advil ® Dual Action with Acetaminophen. DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION ” IS BROKEN OR MISSING. Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage. Distributed by: BIONPHARMA Princeton, NJ 08540 MADE IN INDIA Code: TN/Drugs/TN00002222/2006 948006937 R1025 L0001173 Lot No.: Exp. Date:

PRINCIPAL DISPLAY PANEL ***Compare to the active ingredient in Advil® Dual Action with Acetaminophen a+health dual action pain reliever acetaminophen and ibuprofen (NSAID) tablets, 250 mg/125 mg Contains 2 medicines 400 Caplets** **capsule-shaped tablets Front Back Ply-1 Back Ply-2 front backply backply-2