SPL v1
SPL
SPL Set ID 4870ff00-f727-814d-e063-6394a90a6c8e
Route
ORAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromellose, Unspecified Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Povidone, Unspecified Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;234 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01

Description

Active ingredient (in each tablet) Acetaminophen 325 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

temporarily relieves of minor aches and pains due to:

■ headache

■ muscular aches

■ minor arthritis pain

■ backache

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Dosage and Administration

Directions

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

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 under 12 years:

■ Ask a doctor

Dosage Forms and Strengths

2 in 1 packet; 1 packet in 1 pouch.

Description

Active ingredient (in each tablet) Acetaminophen 325 mg

Section 34088-5

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.

Section 44425-7

■ store at room temperature 59º-86ºF (15º-30ºC)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop using and ask a doctor if

■ pain gets worse and 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

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

■ 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

corn starch, hypromellose, polyethylene glycol, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Section 55105-1

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 325 mg

Ndc 51662 1665 2


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves of minor aches and pains due to:

■ headache

■ muscular aches

■ minor arthritis pain

■ backache

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Dosage and Administration (34068-7)

Directions

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

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 under 12 years:

■ Ask a doctor

Dosage Forms and Strengths (34069-5)

2 in 1 packet; 1 packet in 1 pouch.

Warnings and Precautions (34071-1)

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.

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

Section 44425-7 (44425-7)

■ store at room temperature 59º-86ºF (15º-30ºC)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop using and ask a doctor if

■ pain gets worse and 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

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)

■ 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)

corn starch, hypromellose, polyethylene glycol, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 325 mg

Ndc 51662 1665 2 (NDC 51662-1665-2)


Advanced Ingredient Data


Raw Label Data

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