SPL v1
SPL
SPL Set ID 671adabe-5f82-4599-a133-3f67ccb34079
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S99 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23

Description

Acetaminophen 325 mg

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 325 mg

Uses:
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain from arthritis
  • the common cold 
  • toothache 
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adults 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
  • rash 

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take mote than 10 tablets in 24 hours, unless directed by doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by doctor
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.
Other Information
  • store between 20°-25°C (68°-77°F)
  • read all product information before using
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Pregelatinized Starch, Polyvinyl Pyrrolidone, Microcrystalline Cellulose, Stearic acid powder,  Magnesium Stearate, Hypromellose-5 & 15, Polyethylene Glycol-400, Talc, Titanium Dioxide.

Questions Or Comments?

Call toll free 1-844-832-1138 Monday through Friday 9 AM - 5 PM EST

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 12 years
  • fever gets worse or lasts 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 health professional before use.

Keep Out of Reach of Children.

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.

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Package Label.principal Display Panel

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:
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain from arthritis
  • the common cold 
  • toothache 
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/Fever reducer

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adults 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
  • rash 

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take mote than 10 tablets in 24 hours, unless directed by doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by doctor
Do Not Use (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.
Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • read all product information before using
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

Pregelatinized Starch, Polyvinyl Pyrrolidone, Microcrystalline Cellulose, Stearic acid powder,  Magnesium Stearate, Hypromellose-5 & 15, Polyethylene Glycol-400, Talc, Titanium Dioxide.

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-832-1138 Monday through Friday 9 AM - 5 PM EST

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 12 years
  • fever gets worse or lasts 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 health professional before use.

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 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.

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

Acetaminophen 325 mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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


Raw Label Data

All Sections (JSON)