SPL v1
SPL
SPL Set ID 5017f066-5642-44df-b57b-a827e7dd4f20
Route
ORAL
Published
Effective Date 2020-12-23
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 NOT FINAL Active Since 2020-12-01
Description

Active Ingredient Acetaminophen 500 mg

Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever 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 everyd ay while using this product

Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek mdical help right away.

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 thris product.

Ask a doctor before use if you have liver disease

Ask a doctor before use if you are taking the blodd thinning drug warfarin.

When using this product: Do not exceed recomended dose.

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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Dosage and Administration

Directions Do not take more than directed

 Age  Dose
 Adults and children12 years of age and older  Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. not more than 6 tablespoonfuls in 24 hours
 Children under 12 years  Do not use

Description

Active Ingredient Acetaminophen 500 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get midcal help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6

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

Section 51945-4

Section 53413-1

Question or comments? 1-800-540-3765

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

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)

Directions Do not take more than directed

 Age  Dose
 Adults and children12 years of age and older  Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. not more than 6 tablespoonfuls in 24 hours
 Children under 12 years  Do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever 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 everyd ay while using this product

Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek mdical help right away.

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 thris product.

Ask a doctor before use if you have liver disease

Ask a doctor before use if you are taking the blodd thinning drug warfarin.

When using this product: Do not exceed recomended dose.

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 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get midcal help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question or comments? 1-800-540-3765

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

Acetaminophen 500 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:11.327149 · Updated: 2026-03-14T22:59:04.734496