ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated 
GREENBRIER INTERNATIONAL, INC.

----------

Assured 44-175-Delisted

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. 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 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 25°C (77°F); 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

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
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® Caplets.
50844      REV0617C17510

ITEM# 801831

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

Assured 44-175

Assured 44-175

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;175
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0175-11 in 1 CARTON04/02/199301/29/2023
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/02/199301/29/2023
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(33992-0175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(33992-0175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(33992-0175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(33992-0175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(33992-0175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117597853pack(33992-0175)

Revised: 10/2023
Document Id: 3583b232-8d8c-4c69-9185-ff1a1fb9090a
Set id: e753f792-4962-4165-8d81-9a738a11f039
Version: 16
Effective Time: 20231021
 
GREENBRIER INTERNATIONAL, INC.