Pain Reliever, Acetaminophen Tablets, 325 mg

Manufacturer
Cardinal Health, Inc.
Effective date
2016-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:40

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years takes 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...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

* Acetaminophen 325mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. 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
  • taken with other drugs containing acetaminophen
  • adult 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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, ger 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • takes 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 a doctor
children under 6 years

ask a doctor

Other information

HOW SUPPLIED SECTION

  • store at 20°-25°C (68°-77°F)
  • see and flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-341-9214

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 325mg 100ct bottleAcetaminophen 325mg 100ct bottleAcetaminophen 325mg 100ct cartonAcetaminophen 325mg 100ct cartonAcetaminophen 325mg 50ct cartonAcetaminophen 325mg 50ct cartonAcetaminophen 325mg 50ct bottleAcetaminophen 325mg 50ct bottleAcetaminophen 325mg 500ct bottleAcetaminophen 325mg 500ct bottle

50mg bottle label50mg bottle label

50 mg carton label50 mg carton label

100ct bottle label100ct bottle label

100ct carton label100ct carton label

500ct bottle label500ct bottle label

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-010470000-0104-1, 70000-0104-2, 70000-0104-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2541cdb1-bbbb-63d4-e054-00144ff88e882541cdb1-bbba-63d4-e054-00144ff88e882016-07-15WarningsExact identifier
spl id: 2541cdb1-bbbb-63d4-e054-00144ff88e88
spl set id: 2541cdb1-bbba-63d4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.