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Low dose aspirin - Medication Information

Product NDC Code 71399-8627
Drug Name

Low dose aspirin

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, COATED
RxCUI drug identifier 308416
Application Number part343
Labeler Name Akron Phama
Packages
Package NDC Code Description
71399-8627-1 1000 tablet, coated in 1 bottle (71399-8627-1)
71399-8627-2 120 tablet, coated in 1 bottle (71399-8627-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts 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 while symptoms last do not take more than 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask 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, FD&C yellow#10 al lake, FD&C yellow#6 al lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, 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 relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief.

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 Aspirin ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 D&C YELLOW NO. 10 FERRIC OXIDE RED METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE ASPIRIN ASPIRIN A1

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 description image description

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 have high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic

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 under a doctor's care for any serious condition taking any other drug

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 toll-free 1-877-225-6999 Monday to Friday 9AM to 5PM

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 an allergic reaction occurs. Seek medical help right away. ringing in the ears or loss of hearing occurs pain gets worse or lasts for more that 10 days fever gets worse or lasts for more than 3 days redness or swelling present in the painful area new symptoms occur. These could be signs of a serious condition.

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 15 º -30 º C(59 º -86 º F) read all product information before using

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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Asiprin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. Ths 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 of nonprescription NSAIDS [aspirin, ibuprofin, 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

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