Acetaminophen Extra Strength Caplets

Acetaminophen Extra Strength Caplets
SPL v6
SPL
SPL Set ID d6f968ca-719f-5a68-e053-2995a90a4afa
Route
ORAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Inulin Acacia Guar Gum Agave Tequilana Juice Carnauba Wax Dextrose Maltodextrin Sodium Bicarbonate Lecithin, Sunflower Calcium Carbonate Rice Bran Glyceryl Dibehenate Sunflower Oil Powdered Cellulose Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: G4 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-17

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 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 due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever
Dosage and Administration

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days, unless directed by a doctor

children under 12 years

ask a doctor

Description

Drug Facts

Section 34088-5

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

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 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have 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 ingredients

acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

‡natural

Section 51945-4

Genexa ®

Same active ingredient as Tylenol ®*

0% Artificial Additives

MEDICINE MADE CLEAN

For Adults

Acetaminophen Extra Strength

Pain Reliever

Fever Reducer

50 Caplets | 500 mg each

Section 53413-1

Questions? 1-855-436-3921

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 caplet)

Acetaminophen 500 mg

Section 60561-8

Other information

  • each caplet contains: calcium 12 mg
  • store between 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days, unless directed by a doctor

children under 12 years

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 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 34088-5 (34088-5)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have 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 ingredients

acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

‡natural

Section 51945-4 (51945-4)

Genexa ®

Same active ingredient as Tylenol ®*

0% Artificial Additives

MEDICINE MADE CLEAN

For Adults

Acetaminophen Extra Strength

Pain Reliever

Fever Reducer

50 Caplets | 500 mg each

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

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 caplet)

Acetaminophen 500 mg

Section 60561-8 (60561-8)

Other information

  • each caplet contains: calcium 12 mg
  • store between 20-25°C (68-77°F)

Advanced Ingredient Data


Raw Label Data

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