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Aspirin Low Dose Enteric Coated

Pronunciation

Disclaimer: 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.

Active Ingredient in Each tablet:

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

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, you have lost a lot of fluid due to vomiting or diarrhea.

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 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 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 you are allergic to aspirin or any other pain reliever/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 Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:49483-387-12 120 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
2 NDC:49483-387-10 1000 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
3 NDC:49483-387-00 100000 TABLET, COATED (TABLET) in 1 CARTON
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: 07/2010
 
Time-Cap Labs, Inc



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