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Acetaminophen Extra Strength by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on October 25, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0175

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.

Assured 44-175

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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 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 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: 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

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

Questions or comments?

1-800-426-9391 

Principal Display Panel

ASSURED™ 

COMPARE TO ACTIVE INGREDIENT OF
EXTRA STRENGTH TYLENOL® CAPLETS*

EXTRA STRENGTH
Acetaminophen

• Acetaminophen 500 mg
Pain reliever / Fever reducer

Actual Size
ASPIRIN FREE

40 caplets

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    REV0715B17510
ITEM# 801831

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Assured 44-175



ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
HYPROMELLOSES 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0175-11 BOTTLE in 1 CARTON
140 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 - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(33992-0175), PACK(33992-0175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0175)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0175)

 
GREENBRIER INTERNATIONAL, INC.

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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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