Acetaminophen Regular Strength

Acetaminophen Regular Strength
SPL v4
SPL
SPL Set ID 9d22d642-8aaf-d17e-e053-2995a90ae182
Route
ORAL
Published
Effective Date 2020-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ010 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-24
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 associated with:
  • headache
  • muscular aches 
  • backache
  • arthritis
  • common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever
Warnings

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

  • more than 8 caplets 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
Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
children under 6 years  do not use this adult Regular Strength product in children under 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 drugs 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
Questions?

call toll-free 1-800-935-6737

Other Information
  • store at room temperature. Protect from moisture. 
  • avoid excessive heat 40ºC (above 104º F)
Package Labeling:

Inactive Ingredients

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days. 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: 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 symptoms.

Active Ingredient (in Each caplet)

Acetaminophen 325 mg

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

Structured Label Content

Uses
  • temporarily relieves minor aches and pains associated with:
  • headache
  • muscular aches 
  • backache
  • arthritis
  • common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Warnings

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

  • more than 8 caplets 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
Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
children under 6 years  do not use this adult Regular Strength product in children under 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 drugs 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
Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • store at room temperature. Protect from moisture. 
  • avoid excessive heat 40ºC (above 104º F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days. 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: 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 symptoms.

Active Ingredient (in Each caplet) (Active ingredient (in each caplet))

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.385492 · Updated: 2026-03-14T23:01:35.007581