Your browser does not support JavaScript! CVS ASPIRIN (ASPIRIN) TABLET [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]
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CVS ASPIRIN (aspirin) tablet
[WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for temporary relief of minor aches and pains due to:
  • headache
  • toothache
  • muscle pain
  • menstrual pain
  • the common cold
  • minor pain of arthritis

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 nausea 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 sever allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:

This product contains and (NSAID), which may cause sever stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver sirrhosis, or kidney disease
  • you have asthma
  • you are taking a diurretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

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

These could be signs of a serious condition.

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.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
  • children under 12 years: do not use unless directed by a doctor

Other Information

  • store in a coool dry place at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients

black iron oxide, cellulose, colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

PRODUCT PACKAGING

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

CVS®

pharmacy

ENTERIC

ASPIRIN

Compare to the active ingredient

in Regulare Strength Ecotrin®†

See New Warnings

Information

ALWAYS SAFETY COATED

ASPIRIN REGIMEN-PAIN RELIEVER (NSAID)

325 mg Regular Strength

100 TABLETS

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

50844       REV0110C22712

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com       1-800-shop-CVS

Product Label
CVS ASPIRIN  
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-227
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin325 mg
Inactive Ingredients
Ingredient NameStrength
Ferrosoferric Oxide 
Silicon Dioxide 
D&c Yellow No. 10 
Fd&c Yellow No. 6 
Hypromellose 
Polydextrose 
Polyethylene Glycol 
Propylene Glycol 
Sodium Alginate 
Sodium Bicarbonate 
Stearic Acid 
Talc 
Titanium Dioxide 
Triacetin 
Triethyl Citrate 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-227-121 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:59779-227-131 in 1 CARTON
2250 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/14/1992
Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIBusiness Operations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 8/2010
 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

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