FDA Label for Aspirin Low Dose Enteric Coated
View Indications, Usage & Precautions
Aspirin Low Dose Enteric Coated Product Label
The following document was submitted to the FDA by the labeler of this product Time-cap Labs, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient in Each tablet
Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug
Otc - Ask Doctor
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
Indications & Usage
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.
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
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.
Otc - Ask Doctor/Pharmacist
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
Otc - Do Not Use
Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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 Ingredient
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
Otc - Purpose
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
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