SPL UNCLASSIFIED SECTION.
Drug Facts.
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INACTIVE INGREDIENT SECTION.
Inactive ingredientshypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin.
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DOSAGE & ADMINISTRATION SECTION.
Directions drink full glass of water with each dose Adults and children: (12 years and over) Take 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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INDICATIONS & USAGE SECTION.
UsesFor the temporary relief of minor backache pain.
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OTHER SAFETY INFORMATION.
Other information each caplet contains: magnesium 40 mg store at 25C (77F); excursions permitted between 15-30C (59-86F) tamper evident sealed packets do not use any opened or torn packets.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each caplet) Magnesium Salicylate Tetrahydrate (NSAID) 580 mg(equivalent to 467.2 mg of anhydrous magnesium salicylate)nonsteroidal anti-inflammatory drug.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if 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.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking prescription drug for gout diabetes arthritis.
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OTC - DO NOT USE SECTION.
Do not use if you are allergic to salicylates (including aspirin) or to 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.
PurposePain reliever.
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OTC - QUESTIONS SECTION.
Questions or comments 1-800-480-5855.
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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: feel faint vomit blood have bloody or black stools have stomach pain that does not get better if ringing in the ears or loss of hearing occurs new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than days redness or swelling is presentThese could be signs of serious condition.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
UnishieldBack Pain ReliefPain Relieving Caplets80 Caplets 2 Caplets Per PacketMagnesium Salicylate Tetrahydrate 580 mgPain Reliever (NSAID)Pull To Openo Relieves backaches and muscular aches painsTemporary Relief from Back PainTamper Evident Unit Dose Packets. 074R Back Pain Relief.
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WARNINGS SECTION.
WarningsReyes 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: hives facial swelling asthma (wheezing) shockStomach bleeding warning:This product contains an 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 blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have or more alcohol drinks every day while using this product take more or for longer time than directed.
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