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Generic: acetaminophen, aspirin, caffeine is used for the treatment of Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Apnea Fatigue

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Drug Facts

Otc - Active Ingredient Section


Active ingredients (in each caplet)

Acetaminophen 250 mg.

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose Section


Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Indications & Usage Section


Uses

temporarily relieves minor aches and pains due to

â–  headache â–  muscular aches â–  arthritis pain â–  a cold â–  toothache â–  premenstrual and menstrual cramps

Warnings Section


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

â–  skin reddening â–  bulers â–  rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:

â–  hives â–  facial swelling â–  asthma (wheezing) â–  shock

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

â–  more than 8 caplets in 24 hours, which is the maximum daily amount

â–  with other drugs containing acetaminophen

â–  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:

â–  are age 60 or older

â–  have had stomach ulcers or bleeding problems

â–  take a blood thinning (anticoagulant) or steroid drug

â–  take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

â–  take more or for a longer time than directed

â–  have 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 beat

Otc - Do Not Use Section


Do not use

â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

â–  if you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers

Otc - Ask Doctor Section


Ask a doctor before use if

â–  stomach bleeding warning applies to you

â–  you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

â–  you are taking a diuretic

â–  you have a history of stomach problems such as heartburn

â–  you have asthma

â–  you have liver disease

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you are

â–  taking a prescription drug for gout, diabetes, or arthritis

■ taking any other drug, or under a doctor’s care for any serious condition

Otc - Stop Use Section


Stop use and ask a doctor if

â–  an allergic reaction occurs. Seek medical help right away.

â–  you experience any of the following signs of stomach bleeding:

â–  feel faint â–  vomit blood â–  have bloody or black stools â–  have stomach pain that does not get better

â–  pain gets worse or lasts more than 10 days

â–  fever gets worse or lasts more than 3 days

â–  ringing in the ears or loss of hearing occurs

â–  painful area is red or swollen

â–  any new symptoms appear

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding Section


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 specifically 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. Quick medical attention is critical for adults as well as for children even if you do not notice any

signs or symptoms.

Dosage & Administration Section


Directions

â–  do not use more than directed

â–  drink a full glass of water with each dose

Adults and children: (12 years and over) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

Children under 12 years: Ask a doctor

Other Safety Information


Other information

â–  read all product information before using. Keep box for important information.

■ store at room temperature 68º-77ºF (20º-25ºC)

â–  avoid excessive heat and humidity

â–  tamper evident sealed packets

â–  do not use any opened or torn packets

â–  each caplet contains: Magnesium 0.58 mg

Inactive Ingredient Section


Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

Otc - Questions Section


Questions or comments? 1-800-634-7680

Package Label.principal Display Panel


Medique®

Pain-Off®

Extra Strength Pain Relief

Alivio al dolor extra fuerte

Pain Reliever/Fever Reducer • Acetaminophen 250 mg Aspirin (NSAID) 250 mg

Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 250 mg Aspirina (AINE) 250 mg

Pain Reliever Aid • Caffeine 65 mg

Ayunda al alivio del dolor • Cafina 65 mg

Pull to Open

Tire Para Abrir

200 Caplets (100 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Untarias



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"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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