PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
CVS Pharmacy

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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CVS 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:

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

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 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, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS Health

Compare to the active ingredient in Extra
Strength Tylenol® Rapid Release Gels*

Rapid Release Gelcaps

NDC 59779-519-20

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN, 500 mg
Pain reliever, Fever reducer
Aspirin free

225 GELCAPS

RAPID
RELEASE

Actual Size

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     ORG061551920

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy   CVS.com® 
1-800-SHOP CVS      V-11112

√ CVS Quality
Money Back Guarantee

CVS Health 44-519

CVS Health 44-519


PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorRED, BLUEScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-519-081 in 1 CARTON05/10/2004
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59779-519-121 in 1 CARTON05/10/200410/19/2017
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:59779-519-151 in 1 CARTON05/10/200410/19/2017
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:59779-519-201 in 1 CARTON05/10/2004
4225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:59779-519-05400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
6NDC:59779-519-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
7NDC:59779-519-89225 in 1 BOTTLE; Type 0: Not a Combination Product05/10/200411/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(59779-519) , PACK(59779-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-519)

Revised: 12/2019
Document Id: 53a27bae-af4b-49bd-b614-e141aa8894c0
Set id: 115c48fc-82dd-4bc2-83ae-ffa95deaab3c
Version: 12
Effective Time: 20191209
 
CVS Pharmacy