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← See all Pain Reliever Extra Strength brands

Pain Reliever Extra Strength by CARDINAL HEALTH

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: CARDINAL HEALTH
NDC Code: 37205-594

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

Active ingredient (in each caplet)

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
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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.

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 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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

*may contain this ingredient

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC 37205-594-78

LEADER®

Compare to
Extra Strength
Tylenol®
active ingredient

EXTRA STRENGTH
Pain Reliever
Acetaminophen • Contains No Aspirin
Pain Reliever/Fever Reducer

SATISFACTION
GUARANTEED

100 CAPLETS - 500 mg EACH

Actual Size

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

This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Extra Strength Tylenol®
Caplets.                                                 50844             REV0213A17512

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4527669          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.

Leader 44-175

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, film coated
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
HYPROMELLOSE, UNSPECIFIED 
STEARIC ACID 
CASTOR OIL 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-594-711 BOTTLE in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE
2NDC:37205-594-781 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:37205-594-90500 TABLET, FILM COATED in 1 BOTTLE
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(37205-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(37205-594), PACK(37205-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(37205-594)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(37205-594)

 
CARDINAL HEALTH

← See all Pain Reliever Extra Strength brands

Medically reviewed on Aug 10, 2018

Further information

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

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