Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1148b4d9-fa6a-49e6-9663-17b2c8373846
Route
ORAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Povidone Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: M2A3;57344 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

Description

Acetaminophen 325mg

Purpose

Pain reliever / Fever reducer


Medication Information

Warnings and Precautions

Liver warning:This product contains acetaminophen.  The maximum daily dose of this product is 10 tablets (3,250mg) in 24 hours for adults or 5 tablets (1,625mg) in 24 hours for children.  Severe liver damage may occur if:

Adult takes more than 4,000mg of acetaminphen in 24 hours

Child takes more than 5 doses in 24 hours, which is the maximum daily amount

Taken with other drugs containing acetaminophen

Adult has 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 or 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 user has:

liver disease

is a child with pain of arthritis

Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

Stop use and ask a doctor if:

Adult's pain gets worse or lasts for more than 10 days. 

Child's pain gets worse or lasts more than 5 days.

Fever gets worse or lasts for more than 3 days. 

Redness or swelling is present.

New symptoms occur. 

These could be signs of a serious condition.

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



Purpose

Pain reliever / Fever reducer

Dosage and Administration

Adults and children 12 years and over: 

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 10 tablets in 24 hours, unless directed by a doctor.

Do not use for more than 10 days unless directed by a doctor

Children 6-11 years:

Take 1 tablet every 4 to 6 hours while symptoms last. 

Do not take more than 5 tablets in 24 hours, unless directed by a doctor.

Do not use for more than 5 days unless directed by a doctor

Children under 6 years of age:Ask a doctor

Description

Acetaminophen 325mg

Uses

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

Temporarily reduces fever

Section 51727-6

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4

Active Ingredient

Acetaminophen 325mg

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 immediately (1-800-222-1222).  Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.


Structured Label Content

Uses

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

Temporarily reduces fever

Dosage and Administration (34068-7)

Adults and children 12 years and over: 

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 10 tablets in 24 hours, unless directed by a doctor.

Do not use for more than 10 days unless directed by a doctor

Children 6-11 years:

Take 1 tablet every 4 to 6 hours while symptoms last. 

Do not take more than 5 tablets in 24 hours, unless directed by a doctor.

Do not use for more than 5 days unless directed by a doctor

Children under 6 years of age:Ask a doctor

Warnings and Precautions (34071-1)

Liver warning:This product contains acetaminophen.  The maximum daily dose of this product is 10 tablets (3,250mg) in 24 hours for adults or 5 tablets (1,625mg) in 24 hours for children.  Severe liver damage may occur if:

Adult takes more than 4,000mg of acetaminphen in 24 hours

Child takes more than 5 doses in 24 hours, which is the maximum daily amount

Taken with other drugs containing acetaminophen

Adult has 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 or 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 user has:

liver disease

is a child with pain of arthritis

Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

Stop use and ask a doctor if:

Adult's pain gets worse or lasts for more than 10 days. 

Child's pain gets worse or lasts more than 5 days.

Fever gets worse or lasts for more than 3 days. 

Redness or swelling is present.

New symptoms occur. 

These could be signs of a serious condition.

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



Section 51727-6 (51727-6)

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Purpose

Pain reliever / Fever reducer

Active Ingredient

Acetaminophen 325mg

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 immediately (1-800-222-1222).  Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.


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