EXTRA STRENGTH ACETAMINOPHEN - acetaminophen tablet 
CARDINAL HEALTH

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.

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Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

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.

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 of 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 damamge. In case of overdose, get medical help or contact a Poison Control Center 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

Other information

Inactive ingredients

caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid

*may contain this ingredient

PRODUCT PACKAGING

NDC 37105-594-71

Compare to Extra Strength Tylenol® active ingredient

LEADER®

EXTRA STRENGTH

Pain Reliever

Acetaminophen • Contains No Aspirin

Pain Reliever/Fever Reducer

Caplets

50 CAPLETS - 500 mg EACH

Actual Size

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.

50844    ORG070917515

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4527503

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 NT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader 44-175

Leader 44-175


EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-594
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
STEARIC ACID 
CASTOR OIL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScore no score
ShapeCAPSULESize18mm
FlavorImprint Code 44;175
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:37205-594-711 BOTTLE (1 BOTTLE) in 1 CARTONcontains a BOTTLE
150 TABLET (50 TABLET) in 1 BOTTLEThis package is contained within the CARTON (37205-594-71)
2NDC:37205-594-781 BOTTLE (1 BOTTLE) in 1 CARTONcontains a BOTTLE
2100 TABLET (100 TABLET) in 1 BOTTLEThis package is contained within the CARTON (37205-594-78)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/1993

Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE

Revised: 08/2012 CARDINAL HEALTH