4870ff00-f727-814d-e063-6394a90a6c8e

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.

Active Ingredient

Active ingredient (in each tablet)

Acetaminophen 325 mg

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

Ndc 51662 1665 2


Structured Label Content

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.

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Acetaminophen 325 mg

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.

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

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


Advanced Ingredient Data


Raw Label Data

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