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

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Enteric Coated Aspirin

Cardinal Health


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Active ingredient in each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

Purpose

Pain Reliever

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 are taking a diuretic
  • •you have asthma
  • •you have not been drinking fluids

Ask a doctor or pharmacist before use if you are

  • •taking a prescription drug for diabetes, gout, or arthritis
  • •taking any other drug
  • •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
    • 1.feel faint
    • 2.have bloody or black stools
    • 3.vomit blood
    • 4.have stomach pain that does not get better
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear
  • •ringing in the ears or a loss of hearing occurs

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: consult a doctor

Other information

  • 1.store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
  • 2.use by expiration date on package

Inactive Ingredients

corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil,  polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Enteric Coated Aspirin Uses

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

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed 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: 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.

SKY

Mfd. By: Time-Cap Labs, 7 Michael Avenue Farmingdale, NY 11735

Dist. By: McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road Concord, NC 28027

Repackage by: Cardinal Health Zanesville, OH 43701

L4917308-11013

L4917308-21013

Principal Display Panel

Aspirin DR Enteric Coated Tablets, USP 325 mg

10 Tablets

Enteric Coated Aspirin

Aspirin TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-6828(NDC:63739-523)
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
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
Mineral Oil
polysorbate 80
DIMETHICONE
SILICON DIOXIDE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE
HYPROMELLOSES

Product Characteristics

Color Size Imprint Code Shape
orange 11 mm T ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-6828-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-06-28


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Be sure to consult your doctor before taking any medication!
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