PERCOGESIC- magnesium salicylate tablet, coated

Percogesic by

Drug Labeling and Warnings

Percogesic by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)*

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

Purpose

Pain reliever

Uses

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.

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.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

Other information

• store at room temperature
• protect from moisture
• Magnesium content: 40 mg per tablet

Inactive ingredients

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

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF

48 COATED CAPLETS

INGREDIENTS AND APPEARANCE

PERCOGESIC 
magnesium salicylate tablet, coated

Product 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)