Percogesic 63029-051-48

Percogesic 63029-051-48
SPL v2
SPL
SPL Set ID 8af22641-4280-4123-92bc-35a0cf1716a3
Route
ORAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (467 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: BR Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-01-05

Description

PERCOGESIC- magnesium salicylate tablet, coated Medtech Products Inc. 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. Percogesic Maximum Strength Backache Relief Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

PERCOGESIC- magnesium salicylate tablet, coated Medtech Products Inc. 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. Percogesic Maximum Strength Backache Relief Drug Facts

Keep

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

Uses

Temporarily relieves minor aches and pains associated with

  • backache

  • muscular aches
Section 42229-5

PERCOGESIC- magnesium salicylate tablet, coated Medtech Products Inc.

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.

Percogesic Maximum Strength Backache Relief

Drug Facts

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.

Principal

PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF 48 COATED CAPLETS

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

Do Not Use
  • if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer

  • right before or after heart surgery
Questions?

1-800-443-4908

Other Information
  • store at room temperature  

  • protect from moisture

  • Magnesium content: 40   mg   per   table t
Inactive Ingredients

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

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
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.

Active Ingredient (in Each Tablet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)*

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout

  • diabetes

  • arthritis

  • anticoagulation (thinning the blood)

Structured Label Content

Keep

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

Uses

Temporarily relieves minor aches and pains associated with

  • backache

  • muscular aches
Section 42229-5 (42229-5)

PERCOGESIC- magnesium salicylate tablet, coated Medtech Products Inc.

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.

Percogesic Maximum Strength Backache Relief

Drug Facts

Purpose

Pain reliever

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.

Principal (PRINCIPAL)

PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF 48 COATED CAPLETS

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

Do Not Use (Do not use)
  • if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer

  • right before or after heart surgery
Questions?

1-800-443-4908

Other Information (Other information)
  • store at room temperature  

  • protect from moisture

  • Magnesium content: 40   mg   per   table t
Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Magnesium salicylate tetrahydrate 580 mg (NSAID)*

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • gout

  • diabetes

  • arthritis

  • anticoagulation (thinning the blood)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)