Label: PERCOGESIC- magnesium salicylate tablet, coated
- NDC Code(s): 63029-051-48
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 14, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Uses
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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.Do not use
- if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
- anticoagulation (thinning the blood)
Stop use and ask a doctor if
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.
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERCOGESIC
magnesium salicylate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-051 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 467 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code BR Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-051-48 1 in 1 CARTON 01/05/2010 1 48 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/05/2010 Labeler - Medtech Products Inc. (122715688)
