Acetaminophen 325 Mg

Acetaminophen 325 Mg
SPL v3
SPL
SPL Set ID 3793a17e-13bf-4d27-b8fa-6753b760f820
Route
ORAL
Published
Effective Date 2012-08-31
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 Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;012 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1989-02-05
Description

(in each tablet) Acetaminophen 325 mg

Purpose

Pain Reliever / Fever Reducer

Medication Information

Purpose

Pain Reliever / Fever Reducer

Description

(in each tablet) Acetaminophen 325 mg

Uses

temporarily reduces fever and relieves minor aches and pains caused by

  • common cold
  • headache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
Warnings

Liver warning: 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 tablets in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

do not use with any other drug containing acetaminophen (prescription or non prescription).        If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

Stop use and ask a doctor if

  • adult’s pain gets worse or lasts more than 10 days
  • child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

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

Directions
adults and children 12 years and over 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years ask a doctor
Active Ingredient

(in each tablet)

Acetaminophen 325 mg

Other Information

  • store at 15-30 °C (59-86 °F)

For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Keep Out of Reach of Children.

In case of 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.

Package Label.principal Display Panel

NDC: 17714-012-01 – 100 COUNT

NDC: 17714-012-10 – 1000 COUNT

Structured Label Content

Uses

temporarily reduces fever and relieves minor aches and pains caused by

  • common cold
  • headache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
Purpose

Pain Reliever / Fever Reducer

Warnings

Liver warning: 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 tablets in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

do not use with any other drug containing acetaminophen (prescription or non prescription).        If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

Stop use and ask a doctor if

  • adult’s pain gets worse or lasts more than 10 days
  • child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

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

Directions
adults and children 12 years and over 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years ask a doctor
Active Ingredient

(in each tablet)

Acetaminophen 325 mg

Other Information

  • store at 15-30 °C (59-86 °F)

For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

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

In case of 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.

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

NDC: 17714-012-01 – 100 COUNT

NDC: 17714-012-10 – 1000 COUNT

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.977879 · Updated: 2026-03-14T22:54:57.020531