Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 9e7543d9-6249-45b5-b67d-c1b439423b9c
Route
ORAL
Published
Effective Date 2024-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Citric Acid Monohydrate High Fructose Corn Syrup Polyethylene Glycol 300 Propylene Glycol Water D&c Red No. 33 Fd&c Red No. 40 Saccharin Sodium Anhydrous Sodium Benzoate Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-07-02 Until 2026-11-28

Description

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever 
Warnings

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more than 4 doses in any 24 hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 6 hours while symptoms last
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use 
Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains

    acetaminophen, ask a doctor or pharmacist
Package Label
Major MAPAP
Other Information
  • each 15 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light
Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Principal Display Panel

Major Mapap

ADULT

For ages 12 years and over

Extra Strength Actetaminophen 500 mg

Rapid Burst Cherry

Pain reliever

fever reducer

*COmpare to Extra strength Tylenol® active ingredient

Alcohol free

FL OZ (mL)

Questions or comments?

Call 1-877-753-3935

Monday-Fridat 9AM-5PM EST

Distributed by: MAjor Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Stop Use and Ask A Doctor If

• pain gets worse or lasts for more than 10 days

• fever gets worse or lasts for more than 3 days

• new symptoms occur

• 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance 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 15 Ml)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever 
Purpose

Pain reliever/Fever reducer

Warnings

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more than 4 doses in any 24 hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 6 hours while symptoms last
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use 
Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains

    acetaminophen, ask a doctor or pharmacist
Package Label (Package label)
Major MAPAP
Other Information
  • each 15 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light
Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Principal Display Panel

Major Mapap

ADULT

For ages 12 years and over

Extra Strength Actetaminophen 500 mg

Rapid Burst Cherry

Pain reliever

fever reducer

*COmpare to Extra strength Tylenol® active ingredient

Alcohol free

FL OZ (mL)

Questions or comments?

Call 1-877-753-3935

Monday-Fridat 9AM-5PM EST

Distributed by: MAjor Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• pain gets worse or lasts for more than 10 days

• fever gets worse or lasts for more than 3 days

• new symptoms occur

• 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.

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance 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 15 Ml) (Active Ingredients (in each 15 mL))

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

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

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)