EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, gelatin coated 
GREENBRIER INTERNATIONAL, INC.

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.

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Assured 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take:

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). 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.

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 of symptoms.

Directions

Other information

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl, cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simithicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

*COMPARE TO ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS

Extra Strength
Pain Relief
Acetaminophen
500 mg
Pain reliever / Fever reducer
contains no aspirin

12 Rapid Release gelcaps

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® Rapid Release Gels.
50844          REV0513B51902

Assured 44-519

Assured 44-519

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-0519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
DIMETHICONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 44;519
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0519-21 in 1 CARTON
112 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0519)

Revised: 3/2014
Document Id: 3dfb0931-7f6f-4ad1-ac53-efdb6af21827
Set id: bab1e826-284a-4881-a4a9-1b77c3245099
Version: 2
Effective Time: 20140310
 
GREENBRIER INTERNATIONAL, INC.