DOSAGE & ADMINISTRATION SECTION.

Directionsdo not use more than directeddrink full glass of water with each doseAdults and children (12 years and older): Take tablets with water every hours while symptoms persist. Do not exceed tablets in 24 hours.or as directed by doctor. Children under 12 years: Ask doctor do not use more than directed. drink full glass of water with each dose.

INACTIVE INGREDIENT SECTION.

Inactive ingredientshypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide.

INDICATIONS & USAGE SECTION.

Usestemporarily relieves minor aches and pains associated with:back painmuscular aches. back pain. muscular aches.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredients (in each tablet) Acetaminophen 250 mgCaffeine 50 mgMagnesium Salicylate (NSAID) 290 mgmagnesium (total) 19 mgnonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.

Ask doctor before use ifstomach bleeding warning applies to youyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have history of stomach problems such as heartburn. stomach bleeding warning applies to you. you have high blood pressure, heart disease, liver cirrhosis, or kidney disease. you are taking diuretic. you have history of stomach problems such as heartburn.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you aretaking prescription drugs for gout, diabetes, or arthritistaking the blood thinning drug warfarinunder doctors care for any serious conditiontaking any other drug. taking prescription drugs for gout, diabetes, or arthritis. taking the blood thinning drug warfarin. under doctors care for any serious condition. taking any other drug.

OTC - DO NOT USE SECTION.

Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.if you ever have had an allergic reaction to any other pain relievers/ fever reducersfor more than 10 days unless directed by doctor. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. if you ever have had an allergic reaction to any other pain relievers/ fever reducers. for more than 10 days unless directed by doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of overdose, get medical help or contact 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding, ask health care professional before use. It is especially important not to use salicylates (NSAIDs) during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION.

PurposePain reliever/fever reducerPain reliever aidAnalgesic.

OTC - QUESTIONS SECTION.

Questions or comments 1-800-634-7680.

OTC - STOP USE SECTION.

Stop use and ask 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 betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysringing in the ears or loss of hearing occursredness or swelling is present in the painful areaany new symptoms appears. 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. pain gets worse or lasts more than 10 days. fever gets worse or lasts more than days. ringing in the ears or loss of hearing occurs. redness or swelling is present in the painful area. any new symptoms appears.

OTC - WHEN USING SECTION.

When using this product do not exceed recommended dose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Medique Back Pain-Off Label. Medique(R)Back Pain-OffBack Pain ReliefThis Package is for Households without Young Children.Pull to OpenAches, Fevers Acetaminophen 250 mgPain Reliever Aid Caffeine50 mgPain Relief Magnesium Salicylate (NSAID) 290 mg,100 Tablets(50 2)Tamper Evident Unit Dose Packets. 073R.

SPL UNCLASSIFIED SECTION.

Drug Facts.

WARNINGS SECTION.

Warnings. Reyes 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 doctor because these symptoms could be an early sign of Reyes syndrome, rare but serious illness. Allergy alert: Salicylates (NSAIDs) may cause severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rashIf skin or allergic reaction occurs, stop use and seek medical help right away.. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product. more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. 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: are age 60 or olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this producttake more or for longer time than directed. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. take more or for longer time than directed. Caffeine warning: The recommended dose of this product contains about as much caffeine as 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. Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.if you ever have had an allergic reaction to any other pain relievers/ fever reducersfor more than 10 days unless directed by doctor. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. if you ever have had an allergic reaction to any other pain relievers/ fever reducers. for more than 10 days unless directed by doctor. Ask doctor before use ifstomach bleeding warning applies to youyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diureticyou have history of stomach problems such as heartburn. stomach bleeding warning applies to you. you have high blood pressure, heart disease, liver cirrhosis, or kidney disease. you are taking diuretic. you have history of stomach problems such as heartburn. Ask doctor or pharmacist before use if you aretaking prescription drugs for gout, diabetes, or arthritistaking the blood thinning drug warfarinunder doctors care for any serious conditiontaking any other drug. taking prescription drugs for gout, diabetes, or arthritis. taking the blood thinning drug warfarin. under doctors care for any serious condition. taking any other drug. When using this product do not exceed recommended dose. Stop use and ask 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 betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysringing in the ears or loss of hearing occursredness or swelling is present in the painful areaany new symptoms appears. 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. pain gets worse or lasts more than 10 days. fever gets worse or lasts more than days. ringing in the ears or loss of hearing occurs. redness or swelling is present in the painful area. any new symptoms appears. If pregnant or breast-feeding, ask health care professional before use. It is especially important not to use salicylates (NSAIDs) during the last months of pregnancy unless definitely directed to do so by 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 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.