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

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • the common cold
    • minor pain of arthrtitis
    • menstrual pain
  • or as recommended by your doctor 

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 severe allergic reaction, which may include:

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

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoabulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxes, or others]
  • have 3 or more alcoholic drinks ever 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 or stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic 

Ask a doctor or pharmacist before use if 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
  • have bloody or black stools
  • vomit blood
  • 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 complication 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 overL take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor 

Other information

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

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS
pharmacy®

Compare to the active ingredient in Ecotrin® 81 mg Low Strength Aspirin†

ENTERIC
ASPIRIN
ALWAYS SAFETY COATED
PAIN RELIEVER (NSAID)
ASPIRIN REGIMEN
ALWAYS SAFETY COATED
81 mg low strength

365 COATED TABLETS

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Ecotrin® 81 mg Low Strength Aspirin.
50844    REV0113C43951

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

V-11112

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGCVS 44-439A

CVS 44-439A

ENTERIC ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-439
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
DIMETHICONE 
SODIUM ALGINATE 
SODIUM BICARBONATE 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-439-511 in 1 CARTON
1365 in 1 BOTTLE, PLASTIC
2NDC:59779-439-291 in 1 CARTON
2150 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/14/2004
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-439)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-439)

Revised: 9/2013
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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