Major-apap Max - 7532

Major-apap Max - 7532
SPL v4
SPL
SPL Set ID 2f3af4dd-45d5-87b4-e063-6294a90ab3cc
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Sodium Citrate Methylparaben Fd&c Red No. 40 Propylparaben Citric Acid Water Sucralose Propylene Glycol Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Acetaminophen 500 mg


Medication Information

Warnings and Precautions

Warnings

Liver Warning: This product contains acetaminophen. The maxium daily dose of this product is 90 mL in 24 hours. Severe liver damage may occur if you take

  • more than 120 ml (4,000 mg of acetaminophen) in 24 hours
  • with other drusg containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • if a skin reaction occurs, stop use and seek medical help right away.
Indications and Usage

USES

  • temporarily relieves minor aches and pains due to
  • headache
  • toothache
  • muscular aches
  • the common cold
  • backache
  • minor pain from arthritis
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than directed
  • mL = mililiters
  • measure only with dosing cup provided
  • do not use any other dosing service
  • Adults and children 12 years and over:
  • take 15 to 30 mL every 4 to 6 hours as needed
  • do not take more than 90 mL in 24 hours, unless directed by a doctor
  • Children under 12 years: do not use
Description

Acetaminophen 500 mg

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever get worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warafin

When using this product: Do not exceed recommeneded dose.

Section 51727-6

Inactive ingredients: artificail and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments? 866-595-5598

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Pain Relever/Fever Reducer

Section 55106-9

Acetaminophen 500 mg


Structured Label Content

Indications and Usage (34067-9)

USES

  • temporarily relieves minor aches and pains due to
  • headache
  • toothache
  • muscular aches
  • the common cold
  • backache
  • minor pain from arthritis
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than directed
  • mL = mililiters
  • measure only with dosing cup provided
  • do not use any other dosing service
  • Adults and children 12 years and over:
  • take 15 to 30 mL every 4 to 6 hours as needed
  • do not take more than 90 mL in 24 hours, unless directed by a doctor
  • Children under 12 years: do not use
Warnings and Precautions (34071-1)

Warnings

Liver Warning: This product contains acetaminophen. The maxium daily dose of this product is 90 mL in 24 hours. Severe liver damage may occur if you take

  • more than 120 ml (4,000 mg of acetaminophen) in 24 hours
  • with other drusg containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • if a skin reaction occurs, stop use and seek medical help right away.
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever get worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warafin

When using this product: Do not exceed recommeneded dose.

Section 51727-6 (51727-6)

Inactive ingredients: artificail and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 866-595-5598

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Pain Relever/Fever Reducer

Section 55106-9 (55106-9)

Acetaminophen 500 mg


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