Percogesic Tablet, Coated
FDA Label NDC 63029-051

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Percogesic (NDC 63029-051). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF

48 COATED CAPLETS

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