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Acetaminophen by Cardinal Health, Inc.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cardinal Health, Inc.
NDC Code: 70000-0152

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.

Regular Strength Acetaminophen Tablets, 325 mg

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

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

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 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

  • 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.

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 unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 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 room temperature

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or Comments?

call (800) 795-9775

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

NDC 70000-0152-1

Leader™

Regular Strength

Acetaminophen

Tablets, 325 mg | Pain Reliever / Fever Reducer

For Relief of:

Headache, Fever, Aches and Pains

Aspirin Free

24 TABLETS

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0152
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN 
POVIDONE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeGPIA325
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0152-11 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:70000-0152-3225 TABLET in 1 BOTTLE
3NDC:70000-0152-21 BOTTLE, PLASTIC in 1 CARTON
3100 TABLET in 1 BOTTLE, PLASTIC
4NDC:70000-0152-4500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/28/2016
Labeler - Cardinal Health, Inc. (097537435)

 
Cardinal Health, Inc.

← See all Acetaminophen brands

Medically reviewed on Feb 2, 2017

Further information

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

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