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Acetaminophen by Cardinal Health, Inc.

Medically reviewed on July 16, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cardinal Health, Inc.
NDC Code: 70000-0104

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pain Reliever, Acetaminophen Tablets, 325 mg

Active ingredient (in each tablet)

* Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

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

Warnings

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.

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.

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.

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.

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

Inactive ingredients

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

Questions or comments?

1-888-341-9214

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
STEARIC ACID 
CROSPOVIDONE 
CELLULOSE, MICROCRYSTALLINE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeAPAP;325
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0104-11 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
2NDC:70000-0104-21 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
3NDC:70000-0104-3500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/15/2016
Labeler - Cardinal Health, Inc. (097537435)

 
Cardinal Health, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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