Kortribion Pain Reliever

SPL v3

SPL

SPL Set ID 2e1c7133-c4e8-47bc-e063-6294a90af626

Route

ORAL

Published

Effective Date 2023-08-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Caffeine (65 mg)

Inactive Ingredients

Starch, Corn D&c Red No. 27 Povidone, Unspecified Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Yellow No. 6 Magnesium Stearate Polyethylene Glycol, Unspecified Titanium Dioxide Talc Stearic Acid Silicon Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 5431 Shape: oval Color: red Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-14

Description

Acetaminophen 500 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever aid

Medication Information

Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Uses

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

Purposes

Pain reliever

Pain reliever aid

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

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.

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.

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

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.

Active Ingredients (in Each Tablet)

Acetaminophen 500 mg

Caffeine 65 mg

Structured Label Content

Uses

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

Purposes

Pain reliever

Pain reliever aid

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

Do Not Use (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.

Liver Warning (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 (Caffeine warning)

Other Information (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 (Inactive ingredients)

Questions Or Comments? (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

Ask A Doctor Before Use If (Ask a doctor before use if)

you have liver disease

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

if you are taking the blood thinning drug warfarin

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen 500 mg

Caffeine 65 mg

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pain due to: headache muscular aches", "Purposes": "Pain reliever Pain reliever aid", "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", "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.", "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.", "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", "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.", "Active ingredients (in each tablet)": "Acetaminophen 500 mg Caffeine 65 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:34.427963 · Updated: 2026-03-14T23:07:36.685051