OTC - DO NOT USE SECTION.

Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.

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 (1-800-222-1222) right away.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are taking prescription drug forgoutdiabetesarthritis. gout. diabetes. arthritis.

DOSAGE & ADMINISTRATION SECTION.

Directions. drink full glass of water with each doseadults: caplets every hours, not to exceed caplets in 24 hourschildren under 12 years: do not use unless directed by doctor. drink full glass of water with each dose. adults: caplets every hours, not to exceed caplets in 24 hours. children under 12 years: do not use unless directed by doctor.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin.

INDICATIONS & USAGE SECTION.

Use. for the temporary relief of minor backache pain.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each caplet). Magnesium salicylate tetrahydrate 580 mg (NSAID)nonsteroidal anti-inflammatory drug (equivalent to 467.2 mg of anhydrous magnesium salicylate).

OTC - ASK DOCTOR SECTION.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION.

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

Purpose. Pain reliever.

OTC - QUESTIONS SECTION.

Questions or comments. 1-800-790-6417.

OTC - STOP USE SECTION.

Stop use and ask doctor if. you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better an allergic reaction occurs. Seek medical help right away.new symptoms occurredness or swelling is presentringing in the ears or loss of hearing occurspain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysThese could be signs of serious condition.. you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better vomit blood. feel faint. have bloody or black stools. have stomach pain that does not get better. an allergic reaction occurs. Seek medical help right away.. new symptoms occur. redness or swelling is present. 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 days.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 24 Caplet Bottle Box. NDC 55741-224-24EXTRA STRENGTHDOANS(R)MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)PAIN RELIEVER RELIEVESBACKACHEPAIN24 CAPLETS. Principal Display Panel 24 Caplet Bottle Box.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENeach caplet contains: magnesium 50 mg store at 25C (77F); excursions permitted between 15-30C (59-86F)see end flap for expiration date and lot number. TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN. each caplet contains: magnesium 50 mg store at 25C (77F); excursions permitted between 15-30C (59-86F). see end flap for expiration date and lot number.

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. Magnesium salicylate may cause severe allergic reaction, which may include:hivesfacial swellingasthma (wheezing)shock. hives. facial swelling. asthma (wheezing). shock. 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. Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.. Ask doctor before use if. stomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou have asthmayou are taking diuretic. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, or kidney disease. you have asthma. you are taking diuretic. Ask doctor or pharmacist before use if you are taking prescription drug forgoutdiabetesarthritis. gout. diabetes. arthritis. Stop use and ask doctor if. you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better an allergic reaction occurs. Seek medical help right away.new symptoms occurredness or swelling is presentringing in the ears or loss of hearing occurspain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysThese could be signs of serious condition.. you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better vomit blood. feel faint. have bloody or black stools. have stomach pain that does not get better. an allergic reaction occurs. Seek medical help right away.. new symptoms occur. redness or swelling is present. 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 days. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use magnesium salicylate 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 (1-800-222-1222) right away.