EXTRA STRENGTH HEADACHE RELIEF - acetaminophen, aspirin and caffeine tablet, film 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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Active ingredient(s)

Acetaminophen 250 mg

Aspiring 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Use(s)

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with naussea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

Liver warning: This product contains acetaminophen. Severe lliver damage may occur if you take:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat.

Do not use

  • if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
  • 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
  • stomach bleeding warning appies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac wax, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

The product packaging shown below representa a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active ingredients

in Excedrin® Extra Strength†

SEE NEW WARNINGS INFORMATION

Extra Strength

HEADACHE RELIEF

COATED TABLETS

ACETAMINOPHEN, ASPIRING (NSAID) AND CAFFEINE

PAIN RELIEVER/PAIN RELIEVER AID

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

50844       REV0810D15908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2011 CVS/pharmacy

Product Packaging

Product Packaging


EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-915
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize13mm
FlavorImprint Code 44;159
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59779-915-151 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
150 TABLET, FILM COATED (50 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (59779-915-15)
2NDC:59779-915-081 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
224 TABLET, FILM COATED (24 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (59779-915-08)
3NDC:59779-915-111 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
360 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (59779-915-11)
4NDC:59779-915-121 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
4100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (59779-915-12)
5NDC:59779-915-591 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
5275 TABLET, FILM COATED (275 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (59779-915-59)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/17/1992

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 08/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED