Extra Strength

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Starch, Corn Hypromellose, Unspecified Polyethylene Glycol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-30

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:

• headache • muscular aches • minor pain of arthritis • backache • the common cold • toothache • premenstrual and menstrual cramps

temporarily reduces fever

Section 42229-5

EXTRA STRENGTH

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

See Warnings Information & Directions

See acetaminophen warnings

Do not use if pouch is opened

Child-Resistant Packets

Retain carton for complete product information

Distributed by:

OTC Pharmaceutical Products

Doral, FL 33172

www.otcpharmausa.com © 2023

Section 50565-1

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg in 24 hours, which is the maximum daily amount

• 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.

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 or pharmacist before use if • you are taking the blood thinning drug warfarin

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.

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

Packaging

Directions

• do not use more than directed (see overdose warning)

Adults and children:

(12 years and over)

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets 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

Drug Facts

Other Information

• store at room temperature 59°-86°F (15°-30°C)

• TAMPER EVIDENT child resistant packets

• do not use any opened or torn packets

Inactive Ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

305.594.0480

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

• headache • muscular aches • minor pain of arthritis • backache • the common cold • toothache • premenstrual and menstrual cramps

temporarily reduces fever

Section 42229-5 (42229-5)

EXTRA STRENGTH

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

See Warnings Information & Directions

See acetaminophen warnings

Do not use if pouch is opened

Child-Resistant Packets

Retain carton for complete product information

Distributed by:

OTC Pharmaceutical Products

Doral, FL 33172

www.otcpharmausa.com © 2023

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg in 24 hours, which is the maximum daily amount

• 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.

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 or pharmacist before use if • you are taking the blood thinning drug warfarin

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.

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

Packaging

Directions

• do not use more than directed (see overdose warning)

Adults and children:

(12 years and over)

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets 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

Drug Facts

Other Information (Other information)

• store at room temperature 59°-86°F (15°-30°C)

• TAMPER EVIDENT child resistant packets

• do not use any opened or torn packets

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

305.594.0480

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 500 mg

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information