Aspirin Low Dose Enteric Coated

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

Ask a doctor before use if: stomach bleeding waring 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, hou have lost a lot of fluid due to vomiting or diarhea

Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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 reactino 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, hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription 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.

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis; under a doctor's care for any serious condition; taking any other drug

Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer

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, 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

If pregnant or breast-feeding, ask a health profession 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 the 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years - consult a doctor

Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, itianium dioxide

Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

ASPIRIN  LOW DOSE ENTERIC COATED aspirin  tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-387 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin (aspirin) aspirin 81 mg

Inactive Ingredients Ingredient Name Strength anhydrous lactose   carnauba wax   SILICON DIOXIDE   croscarmellose sodium   D&C YELLOW NO. 10   IRON   METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A   CELLULOSE, MICROCRYSTALLINE   DIMETHICONE   POLYSORBATE 80   SODIUM HYDROXIDE   SODIUM LAURYL SULFATE   TALC   TITANIUM DIOXIDE   triethyl citrate

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code embossed;upper;heart;lower;plain Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-387-12 120 TABLET In 1 BOTTLE, PLASTIC None 2 49483-387-10 1000 TABLET In 1 BOTTLE, PLASTIC None 3 49483-387-00 100000 TABLET In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/28/2010

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Operations
Time-Cap Labs, Inc		037052099	manufacture

Revised: 07/2010Time-Cap Labs, Inc

More Aspirin Low Dose Enteric Coated resources

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• 11 Reviews for Aspirin Low Dose Enteric Coated - Add your own review/rating

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