SPL v1
SPL
SPL Set ID 915c4608-af1b-4119-8291-4ce9fd701d76
Route
ORAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Active Ingredient in each 15 mL Tablespoonful Acetaminophen 500 mg


Medication Information

Warnings and Precautions

Warnings

Liver Warning:This product contains acetaminophen. The maximurr

daily dose of fhis product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if you take

• more than 8 tablespoonfuls (4,000 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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Dosage and Administration
 Age Dose 
 adults and children 12 years of age and older Take 1 to 2 Tablespoonfuls every 4 to 6 hours as needed; not more than 6 tablespoonsfuls in 24 hours 
 children under 12 years  Do not use 

Description

Active Ingredient in each 15 mL Tablespoonful Acetaminophen 500 mg

Section 50565-1

Keep out of reach of children. 

Section 50566-9

Stop use and ask a doctor If • pain gets worse or lasts more than

10 days • fever gets 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 octor or pharmacist.

• if you are allergic to acetaminophen or any of the inactive

ingredients in this product

Ask a doctor before use ff rou have liver disease.

Ask a doctor before use ff you are taking the blood thinning

drug wartarin.

When using this product Do not exceed recommended dose.

Section 51727-6

Inactive ingredients: artificial 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? call toll free 1-800-630-8895

Section 53414-9

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

Section 55105-1

Purpose

Pain Reliever/Fever Reducer

Section 55106-9

Active Ingredient

in each 15 mL Tablespoonful

Acetaminophen 500 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Dosage and Administration (34068-7)
 Age Dose 
 adults and children 12 years of age and older Take 1 to 2 Tablespoonfuls every 4 to 6 hours as needed; not more than 6 tablespoonsfuls in 24 hours 
 children under 12 years  Do not use 

Warnings and Precautions (34071-1)

Warnings

Liver Warning:This product contains acetaminophen. The maximurr

daily dose of fhis product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if you take

• more than 8 tablespoonfuls (4,000 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.

Section 50565-1 (50565-1)

Keep out of reach of children. 

Section 50566-9 (50566-9)

Stop use and ask a doctor If • pain gets worse or lasts more than

10 days • fever gets 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 octor or pharmacist.

• if you are allergic to acetaminophen or any of the inactive

ingredients in this product

Ask a doctor before use ff rou have liver disease.

Ask a doctor before use ff you are taking the blood thinning

drug wartarin.

When using this product Do not exceed recommended dose.

Section 51727-6 (51727-6)

Inactive ingredients: artificial 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? call toll free 1-800-630-8895

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active Ingredient

in each 15 mL Tablespoonful

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)