Acetaminophen Extra Strength

Acetaminophen Extra Strength
SPL v1
SPL
SPL Set ID 48dc8d92-16ee-b359-e063-6294a90a26af
Route
ORAL
Published
Effective Date 2026-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Water Sucralose Anhydrous Citric Acid Polyethylene Glycol 350 Propylene Glycol Methylparaben Propylparaben Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Dosage and Administration

Directions

  • do not take more than directed

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 Tablespoonfuls in 24 hours
Children under 12 years Do not use

Description

Acetaminophen 500 mg

Uses
  • Temporarily relieves minor aches and pains
    • temporarily reduces fever
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 50567-7

When using this product do not exceed recommended dose

Section 50568-5

Ask a doctor before use if you have taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your childhas liver disease

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.
Section 51727-6

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Question or Comments?

call 305-592-9216 or [email protected]

Section 60561-8

Other information

  • store at room temperature between 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing
Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take

  • more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using the 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.

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 conbtact a Poison Control Center right away.  Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

Active Ingredient (in Each 15 Ml Teaspoonful)

Acetaminophen 500 mg


Structured Label Content

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 children 12 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

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 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

Ask a doctor before use if you have taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your childhas liver disease

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.
Section 51727-6 (51727-6)

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question or Comments?

call 305-592-9216 or [email protected]

Section 60561-8 (60561-8)

Other information

  • store at room temperature between 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing
Purpose

Pain reliever/fever reducer

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take

  • more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using the 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.

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.)

In case of overdose, get medical help or conbtact a Poison Control Center right away.  Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

Active Ingredient (in Each 15 Ml Teaspoonful) (Active ingredient (in each 15 mL-teaspoonful))

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

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