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| Product NDC Code | 49483-381 | ||||||
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| Drug Name | Low dose aspirin enteric safety coated |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, DELAYED RELEASE | ||||||
| RxCUI drug identifier | 308416 | ||||||
| Application Number | part343 | ||||||
| Labeler Name | Time-Cap Labs, Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Aspirin 81 mg (NSAID*)................................Pain reliever *nonsteroidal anti-inflammatory drug
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Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
| anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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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Purpose
Information about the drug product’s indications for use.Purpose: Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Low Dose Aspirin Enteric Safety Coated Aspirin CROSCARMELLOSE SODIUM CROSCARMELLOSE FERRIC OXIDE YELLOW PROPYLENE GLYCOL SHELLAC TALC METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) SODIUM HYDROXIDE DIMETHICONE SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE TRIETHYL CITRATE POLYSORBATE 80 ANHYDROUS LACTOSE FERROSOFERRIC OXIDE ASPIRIN ASPIRIN BROWN IRON OXIDE D&C YELLOW NO. 10 HYPROMELLOSES MICROCRYSTALLINE CELLULOSE MINERAL OIL POTASSIUM HYDROXIDE T81
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.IMAGE OF BOTTLE LABEL
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
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Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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 ringing in the ears or a loss of hearing occurs
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Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
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Storage and handling
Information about safe storage and handling of the drug product.store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
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Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they 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. 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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
Warnings
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Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API