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Acetaminophen Extra Strength by Cardinal Health

Medically reviewed on June 18, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 70000-0312

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.

Leader 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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 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
  • 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0312-1

Extra Strength
Acetaminophen

Gelcaps, 500 mg | Pain Reliever / Fever Reducer

Rapid Release
For Adults
Aspirin Free

50 GELCAPS

Actual Size

COMPARE TO EXTRA STRENGTH TYLENOL® active ingredient*

100% Money Back Guarantee

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.

50844 ORG041751915

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

©2017 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER,
and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

All LEADER™ Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

Leader 44-519

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0312
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POVIDONE 
PROPYLENE GLYCOL 
SHELLAC 
STEARIC ACID 
TITANIUM DIOXIDE 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STARCH, CORN 
Product Characteristics
ColorBLUE, REDScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0312-11 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
2NDC:70000-0312-21 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
3NDC:70000-0312-31 BOTTLE in 1 CARTON
3225 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0312)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(70000-0312), PACK(70000-0312)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0312)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(70000-0312)

 
Cardinal Health

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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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