SPL v1
SPL
SPL Set ID 35478de8-50d0-5d0a-e063-6294a90a88ba
Route
ORAL
Published
Effective Date 2025-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (0.5 g)
Inactive Ingredients
Titanium Dioxide Stearic Acid Starch, Corn Sodium Starch Glycolate Type A Potato Polyethylene Glycol, Unspecified Hypromelloses Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-30

Description

Active ingredient (in each tablet) Acetaminophen 500 mg


Medication Information

Warnings and Precautions

Warnings

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

more than 8 tablets 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

Uses

For the temporary relief of minor aches and pains associated with

headache

muscular aches

minor arthritis pain

common cold

toothache

menstrual cramps

For the reduction of fever.

Dosage and Administration

Directions

do not use more than directed

Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:Do not give to children under 12 years of age

Dosage Forms and Strengths

51662-1666-2 2Pack

Description

Active ingredient (in each tablet) Acetaminophen 500 mg

Section 50565-1

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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.

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if

symptoms do not improve

new symptoms occur

pain or fever persists or gets worse

redness or swelling is present

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

Section 50569-3

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

Section 51727-6

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Section 51945-4

Section 55105-1

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8

Other information

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

tamper-evident sealed packets

do not use any opened or torn packets

Questions

Questions or comments?1-800-777-4908


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains associated with

headache

muscular aches

minor arthritis pain

common cold

toothache

menstrual cramps

For the reduction of fever.

Dosage and Administration (34068-7)

Directions

do not use more than directed

Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:Do not give to children under 12 years of age

Dosage Forms and Strengths (34069-5)

51662-1666-2 2Pack

Warnings and Precautions (34071-1)

Warnings

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

more than 8 tablets 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 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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.

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if

symptoms do not improve

new symptoms occur

pain or fever persists or gets worse

redness or swelling is present

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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8 (60561-8)

Other information

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

tamper-evident sealed packets

do not use any opened or torn packets

Questions (QUESTIONS)

Questions or comments?1-800-777-4908


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)