EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, gelatin coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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

  • temporarily relieves minor aches and ains due to:
    • headache
    • backache
    • toothache
    • the common cold
    • minor pain of arthritis
    • muscular aches
    • premesntrual and menstrual cramps
  • temporarily reduces fever

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:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while uding this product

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

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 to 6 hours while symptoms last
    • do not take more than 8 gelcaps in 24 hours
    • do not take for more than 10 days unlesss directed by a doctor
  • children under 12 years of age: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

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

CVS
pharmacy®

Compare to the active ingredient in TYLENOL® Rapid Release Gels

Extra Strength
PAIN RELIEF
RAPID RELEASE GELCAPS
ACETAMINOPHEN
CONTAINS NO ASPIRIN
Pain reliever / Fever reducer

225 GELCAPS - 500 mg each
FAST RELEASE

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

50844          REV0213E51908

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com        1-800-shop-CVS

CVS 44-519

CVS 44-519

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-519
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
ColorRED (and blue with grey band) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-519-081 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
2NDC:59779-519-111 in 1 CARTON
260 in 1 BOTTLE, PLASTIC
3NDC:59779-519-121 in 1 CARTON
3100 in 1 BOTTLE, PLASTIC
4NDC:59779-519-151 in 1 CARTON
450 in 1 BOTTLE, PLASTIC
5NDC:59779-519-201 in 1 CARTON
5225 in 1 BOTTLE, PLASTIC
6NDC:59779-519-291 in 1 CARTON
6150 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-519)

Revised: 9/2013
Document Id: 285d631c-0999-4463-93dd-7b3fcb03223d
Set id: 115c48fc-82dd-4bc2-83ae-ffa95deaab3c
Version: 4
Effective Time: 20130920
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED