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Leader Extra Strength Pain Relief

Medically reviewed on August 23, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 49781-088

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.

DRUG FACTS

Active ingredient

Acetaminophen


Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dosse 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

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 damamge. 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 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients  

Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid

LEADER EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-088
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize12mm
FlavorImprint CodePH044
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-088-081 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/23/2014
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel(49781-088), repack(49781-088)
Establishment
NameAddressID/FEIOperations
Pharbest557054835manufacture(49781-088)

 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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