DOSAGE & ADMINISTRATION SECTION.
Directions. drink full glass of water with each doseadults and children 12 years and over: 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 and children 12 years and over: caplets every hours, not to exceed caplets in 24 hours. children under 12 years: do not use unless directed by doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin.
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INDICATIONS & USAGE SECTION.
Use. for the temporary relief of minor backache pain.
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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).
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if. you have asthmastomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diuretic. you have asthma. 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 are taking diuretic.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking prescription drug forgoutdiabetesarthritis. gout. diabetes. arthritis.
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OTC - DO NOT USE SECTION.
Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
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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.
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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 at 20 weeks or later in pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.
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OTC - PURPOSE SECTION.
Purpose. Pain reliever.
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OTC - QUESTIONS SECTION.
Questions or comments. 1-800-790-6417.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. an allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better ringing in the ears or loss of hearing occurspain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysnew symptoms occurredness or swelling is presentThese could be signs of serious condition.. an allergic reaction occurs. Seek medical help right away.. 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. 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. new symptoms occur. redness or swelling is present.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 24 Caplet NDC 55741-600-34MAXIMUM STRENGTHDOANS(R)MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)PAIN RELIEVER BACK PAIN RELIEF24 CAPLETS.
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SPL UNCLASSIFIED SECTION.
Carton. Carton. Bottle label.
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STORAGE AND HANDLING SECTION.
Other information. each caplet contains: magnesium 45 mg store at 25C (77F); excursions permitted between 15-30C (59-86F)see end flap for expiration date and lot number. each caplet contains: magnesium 45 mg store at 25C (77F); excursions permitted between 15-30C (59-86F). see end flap for expiration date and lot number.
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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. you have asthmastomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking diuretic. you have asthma. 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 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. an allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding: vomit bloodfeel fainthave bloody or black stoolshave stomach pain that does not get better ringing in the ears or loss of hearing occurspain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysnew symptoms occurredness or swelling is presentThese could be signs of serious condition.. an allergic reaction occurs. Seek medical help right away.. 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. 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. new symptoms occur. redness or swelling is present. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in 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.
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