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Pain Reliever Extra Strength by CARDINAL HEALTH

Medically reviewed on Oct 6, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: CARDINAL HEALTH
NDC Code: 37205-593

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 44-531 Delisted

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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 

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  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 6 hours while symptoms last
    • do not take more than 6 tablets 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: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage 

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

Inactive ingredients

corn starch, dextrose monohydrate, FD&C red #40, FD&C yellow #6, maltodextrin, povidone, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, sucralose, titanium dioxide 

Questions or comments?

 1-800-426-9391

Principal display panel

NDC 37205-593-78

Compare to Extra Strength Tylenol® EZ Tabs
active ingredient*

LEADER®

EXTRA STRENGTH
Pain Reliever
Acetaminophen
 

Pain Reliever/Fever Reducer • Contains No Aspirin

Easy to Swallow
Sweet Coated

Easy Tabs

100 TABLETS - 500 mg EACH

Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® EZ Tabs.
50844    REV0913B53112

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4527750   www.myleader.com    1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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

Leader44-531A

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-593
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
TITANIUM DIOXIDE 
STARCH, CORN 
DEXTROSE MONOHYDRATE 
MALTODEXTRIN 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorRED (sweet coating) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-593-711 BOTTLE in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE
2NDC:37205-593-781 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/200508/29/2020
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(37205-593)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(37205-593)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(37205-593)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(37205-593)

 
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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