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

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Safety Coated Enteric Aspirin

WALGREEN CO.

Walgreens 44-227


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Safety Coated Enteric Aspirin Uses

  • for the temporary relief of minor aches and pains due to:

    • headache

    • muscle pain

    • toothache

    • 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 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 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
  • redness or swelling is present
  • 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

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

Safety Coated Enteric Aspirin Other information

  • store in a cool dry place at controlled room temperature 15°-30°C (59°-86°F)

  • use by expiration date on package

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

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0227-57

ENTERIC COATED
REGULAR STRENGTH
Aspirin 325
325 mg / Pain Reliever (NSAID)

  • Safety coated for aspirin regimen users
  • Easy to swallow

125 ENTERIC COATED TABLETS

Compare to Ecotrin® active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2010
ǂǂThis product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Ecotrin®.
50844    ORG011022757

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Safety Coated Enteric Aspirin
Walgreens 44-227

Safety Coated Enteric Aspirin

Aspirin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0227
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POLYVINYL ACETATE PHTHALATE
propylene glycol
SODIUM ALGINATE
SODIUM BICARBONATE
STEARIC ACID
talc
titanium dioxide
triacetin
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 11 mm 44;227 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 125 in 1 BOTTLE, PLASTIC
2 NDC:0363-0227-14 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1992-12-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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