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Pain Reliever Extra Strength by Topco Associates, LLC

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Topco Associates, LLC
NDC Code: 36800-531

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.

Topcare 44-531

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches 
    • headache
    • the common cold
    • toothache
    • minor pain of arthritis
    • 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 in 24 hours, which is the maximum daily amount
  • 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:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and 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 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: ask a doctor

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, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

TopCare®

NDC 36800-531-06

EXTRA STRENGTH
Pain
Reliever
ACETAMINOPHEN

PAIN RELIEVER / FEVER REDUCER

• Easy to swallow
• Contains no aspirin
• Sweet coated 

ACTUAL
SIZE

200 TABLETS - 500 mg EACH

COMPARE TO
EXTRA STRENGTH
TYLENOL® 
active ingredient*

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

QUALITY GUARANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLIAGE, IL 60007
©TOPCO LNK1216
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com


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

50844   ORG081653106

TopCare 44-531

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-531
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
STARCH, CORN 
TITANIUM DIOXIDE 
POVIDONE 
D&C YELLOW NO. 10 
STEARIC ACID 
SUCRALOSE 
TALC 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-531-06200 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(36800-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(36800-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(36800-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(36800-531)

 
Topco Associates, LLC

← See all Pain Reliever Extra Strength brands

Medically reviewed on Jan 15, 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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