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Dye-free aspirin 81 - Medication Information

Product NDC Code 0363-6455
Drug Name

Dye-free aspirin 81

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]
Active Ingredients
Aspirin 81 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 308416
Application Number M013
Labeler Name WALGREENS
Packages
Package NDC Code Description
0363-6455-10 1000 tablet in 1 bottle (0363-6455-10)
0363-6455-12 120 bottle in 1 carton (0363-6455-12) / 120 tablet in 1 bottle
0363-6455-50 500 tablet in 1 bottle (0363-6455-50)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, 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 • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. • ask your doctor about other uses for enteric coated 81 mg Aspirin.

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.
Dye-Free Aspirin 81 Aspirin ASPIRIN ASPIRIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 SODIUM HYDROXIDE TALC ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE DIMETHICONE SODIUM LAURYL SULFATE STARCH, CORN

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.
walgreens-aspirin-fp-1000s-label 480R-WG-Aspirin81mg-label-120s 480R-WG-Aspirin81mg-ifc-120s 480R-WG-Aspirin81mg-label-500

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
DRUG FACTS

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 you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

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 ● gout ● diabetes ● arthritis

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 if you have ever had an allergic reaction to this product or any of its ingredients

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 (1-800-222-1222) right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information • Store at room temperature. Avoid excessive heat above 40°C (104°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-877-290-4008

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 an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools 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 new symptoms occur ringing in the ears or a loss of hearing occurs

Pregnancy or breast feeding

Pregnancy or Breast feeding
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.

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 • asthma (wheezing) • shock 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 problem 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 Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug for ● gout ● diabetes ● arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools 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 new symptoms occur 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 (1-800-222-1222) right away.

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