Kortribion Pain Reliever Tablet, Film Coated
FDA Label NDC 69729-793

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Kortribion Pain Reliever (NDC 69729-793). 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 active ingredients (in each tablet), purposes, uses, liver warning, caffeine warning, do not use, ask a doctor before use if, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Caffeine Warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask A Doctor Before Use If

you have liver disease

Ask A Doctor Or Pharmacist

if you are taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • any new symptoms occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not exceed recommended dosage
  • adults and children 12 years and over: take 2 tablets every 6 hours; do not take more than 6 tabletsin 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

Questions Or Comments?

Call Medimex Inc. 302-318-1359 Monday through Friday 9AM-5PM EST

Principal Display Panel

NDC 69729-793-24

KORTRIBION

Treat Pain or Inflammation caused by conditions such as:

Alivio temporal de dolores leves y malestares debidos a:

Joint Pain

Articulaciones

Headache

Dolor de cabeza

Muscle Aches

Dolores musculares

Back Ache

Dolores de espalda

Inflamation

Inflamación

Arthritis

Artitris

Box with 24 caplets

Analgésico/Pain Reliever

Exclusively distributed by:

OPMX Chula Vista, CA 91910

Phone: 619-600-5632

* Please review the disclaimer below.