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FDA LABEL GENERIC: Magnesium Salicylate MFR: Medtech Products Inc.

Percogesic Backache 580 Mg Oral Tablet

PERCOGESIC- magnesium salicylate tablet, coated Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Percogesic Maximum Strength Backache Relief

Drug Facts

Magnesium salicylate tetrahydrate 580 mg (NSAID)*

*nonsteroidal anti-inflammatory drug (equivalent to 467 mg of magnesium salicylate anhydrous)

Pain reliever

INDICATIONS AND USAGE

Temporarily relieves minor aches and pains associated with

backache
muscular aches

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: Magnesium salicylate may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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.

if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer
right before or after heart surgery
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn, upset stomach or stomach pain
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic
you are on a magnesium-restricted diet

taking a prescription drug for

gout
diabetes
arthritis
anticoagulation (thinning the blood)

you experience any of the following signs of stomach bleeding:

feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.  
new symptoms occur
ringing in the ears or loss of hearing occurs  
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present. These could be signs of a serious condition.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE AND ADMINISTRATION

do not take more than 4 doses in 24 hours. Drink a full glass of water with each dose.

Adults   and   children   12   years   of   age   and   older:  take 2 tablets every 6 hours while symptoms persist.

Children   under   12   years   of   age:  ask a doctor

store at room temperature  
protect from moisture
Magnesium content: 40   mg   per   table t

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, silica, stearic acid, talc, titanium dioxide

1-800-443-4908

ASK A DOCTOR

PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF 48 COATED CAPLETS