Enteric Coated Aspirin description, usages, side effects, indications, overdosage, supplying and lots more!

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Enteric Coated Aspirin

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

HealthCare 44-600A


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Pain reliever 

for the temporary relief of minor aches and pains or as recommended by your doctor

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:  

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

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 (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 cirrhosis or kidney disease
  • you have asthma
  • you are taking a diuretic 

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 experienece 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
  • 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 (1-800-222-1222) right away. 

  • drink a full glass of water with each dose
  • adults and children 12 years and over: 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 
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silca, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate 

Call 1-800-426-9391 

Principal Display Panel

HEALTHCARE

NDC 64092-119-60

†Compare to The Active Ingredient of Bayer® Low Dose Aspirin

Adult Low Dose
Aspirin 81 mg

• Pain Reliever (NSAID)
Delayed Release
• Aspirin Regimen

ENTERIC COATED

60 TABLETS 

†This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
50844        REV0613A60011

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

Enteric Coated Aspirin
Healthcare 44-600A

Enteric Coated Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-199
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
HYPROMELLOSES
METHACRYLIC ACID
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
propylene glycol
SHELLAC
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
YELLOW 6 mm L ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:64092-199-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-02-12


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Be sure to consult your doctor before taking any medication!
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