Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f818417e-0b31-4fe7-8313-4160a00b248a
Route
ORAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Povidone Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: M2A4;57344 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

Description

Acteminophen 500 mg

Purpose

Pain reliever / Fever reducer


Medication Information

Purpose

Pain reliever / Fever reducer

Dosage and Administration

Do not take more than directed (see overdose warning)  

Adults and children 12 years of age 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 more than 10 days unless directed by a doctor

Children under 12 years of age:ask a doctor

Description

Acteminophen 500 mg

Uses

Temporary relief of minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps

Temporarily reduces fever.

Section 51727-6

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4

Warnings

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

-Adults take more than 4,000mg 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.

Do not use:

-If you are allergic to Acetaminophen or any of the inactive ingredients in this product.

-With other products containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you haveliver disease

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

Stop use and ask a doctor if:

-Pain gets worse or lasts for more than 10 days

-Fever gets worse or lasts for more than 3 days

-New symptoms occur

-Redness or swelling is present

These could be signs of a serious condition.

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

Active Ingredient

Acteminophen 500 mg

Keep Out of Reach of Children

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 critcal for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Uses

Temporary relief of minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps

Temporarily reduces fever.

Dosage and Administration (34068-7)

Do not take more than directed (see overdose warning)  

Adults and children 12 years of age 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 more than 10 days unless directed by a doctor

Children under 12 years of age:ask a doctor

Section 51727-6 (51727-6)

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Purpose

Pain reliever / Fever reducer

Warnings

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

-Adults take more than 4,000mg 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.

Do not use:

-If you are allergic to Acetaminophen or any of the inactive ingredients in this product.

-With other products containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you haveliver disease

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

Stop use and ask a doctor if:

-Pain gets worse or lasts for more than 10 days

-Fever gets worse or lasts for more than 3 days

-New symptoms occur

-Redness or swelling is present

These could be signs of a serious condition.

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

Active Ingredient

Acteminophen 500 mg

Keep Out of Reach of Children (Keep out of reach of Children)

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 critcal for adults as well as for children even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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