Acetaminophen

SPL v5

SPL

SPL Set ID 8b838af4-a74d-47b4-952e-dcf5598b08e1

Route

ORAL

Published

Effective Date 2022-09-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Povidone Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: PH020 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-01-01

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

for the temporary relief of minor aches and pains due to:

Headache

Muscular aches

Backache

Toothache

Premenstrual and menstrual cramps

Temporally reduces fever.

Directions

Directions

Adults and Children

12 years and older

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 12 tablets in 24 hours

Children

6 to 11 years

Take 1 tablet every 4 to 6 hours while symptoms last

Do not take more than 5 tablets in 24 hours

Children under

6 years

Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription)
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

Drug Facts

Other Information

store at room temperature 20°-25°C (68-77°F)

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms.

Do not take more tahn directed (see overdose warning)

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Acetaminophen 100 Tablet

• Liver Warning Warnings

this product contains Acetaminophen. Severe liver damage may occur if

adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Stop Use and Ask A Doctor If

Pain gets worse or lasts more than 10 days in adults.

Pain gets worse or lasts more than 5 days in children under under 12 years

Fever gets worse or last more than 3 days

new symptoms occur

Redness or swelling is present. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a doctor before use.

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Keep Out of the Reach of Children.

Ask A Doctor Before Use If the User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

for the temporary relief of minor aches and pains due to:

Headache

Muscular aches

Backache

Toothache

Premenstrual and menstrual cramps

Temporally reduces fever.

Purpose

Pain reliever/fever reducer

Directions

Directions

Adults and Children

12 years and older

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 12 tablets in 24 hours

Children

6 to 11 years

Take 1 tablet every 4 to 6 hours while symptoms last

Do not take more than 5 tablets in 24 hours

Children under

6 years

Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription)
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

Drug Facts

Other Information (Other information)

store at room temperature 20°-25°C (68-77°F)

Overdose Warning: (Overdose warning:)

Do not take more tahn directed (see overdose warning)

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Acetaminophen 100 Tablet (Acetaminophen 100 tablet)

• Liver Warning Warnings (• Liver warning Warnings)

this product contains Acetaminophen. Severe liver damage may occur if

adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Pain gets worse or lasts more than 10 days in adults.

Pain gets worse or lasts more than 5 days in children under under 12 years

Fever gets worse or last more than 3 days

new symptoms occur

Redness or swelling is present. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

Active Ingredient (in Each Tablet) (Active Ingredient (in each Tablet))

Acetaminophen 325 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

[{"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of minor aches and pains due to: Headache Muscular aches Backache Toothache Premenstrual and menstrual cramps Temporally reduces fever.", "Purpose": "Pain reliever/fever reducer", "Directions": "Directions Adults and Children 12 years and older Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 to 11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. ", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription) 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", "Other information": "store at room temperature 20°-25°C (68-77°F)", "Overdose warning:": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms. Do not take more tahn directed (see overdose warning)", "Inactive Ingredients": "Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid", "• Liver warning Warnings": "this product contains Acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product", "Stop use and ask a doctor if": "Pain gets worse or lasts more than 10 days in adults. Pain gets worse or lasts more than 5 days in children under under 12 years Fever gets worse or last more than 3 days new symptoms occur Redness or swelling is present. These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a doctor before use.", "Active Ingredient (in each Tablet)": "Acetaminophen 325 mg", "Ask a doctor before use if the user has": "liver disease", "Ask a doctor or pharmacist before use if the user is": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:25.406259 · Updated: 2026-03-14T23:01:57.446196