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Aspirin - Medication Information

Product NDC Code 17714-009
Drug Name

Aspirin

Type Generic
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, CHEWABLE
RxCUI drug identifier 318272
Application Number part343
Labeler Name Advance Pharmaceutical Inc.
Packages
Package NDC Code Description
17714-009-36 36 carton in 1 bottle (17714-009-36) / 1 tablet, chewable in 1 carton
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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 this product does not contain directions or complete warnings for adult use administer only under adult supervision if possible, use weight to dose, otherwise use age repeat dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours drink water with each dose Weight (lbs.) Age (years) Dose 77 – 83 11 to under 12 4 – 6 tablets 66 – 76 9 to under 11 4 - 5 tablets 46 – 65 6 to under 9 4 tablets 36 – 45 4 to under 6 3 tablets 32 – 35 3 to under 4 2 tablets under 32 under 3 ask a doctor DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours. Children under 12 years: ask a doctor
Weight (lbs.) Age (years) Dose
77 – 83 11 to under 12 4 – 6 tablets
66 – 76 9 to under 11 4 - 5 tablets
46 – 65 6 to under 9 4 tablets
36 – 45 4 to under 6 3 tablets
32 – 35 3 to under 4 2 tablets
under 32 under 3 ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

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.
Use 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 effect may occur.

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.
Aspirin Aspirin STARCH, CORN FD&C YELLOW NO. 6 MAGNESIUM STEARATE ORANGE SILICON DIOXIDE SUCROSE ASPIRIN ASPIRIN AP;009

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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-009-36 – 36 COUNT 655159bb-figure-01 655159bb-figure-02

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.
Other Information store at 15-30 °C (59-86 °F)

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.

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 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

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 signs of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives asthma (wheezing) shock facial swelling Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child has had stomach ulcers or bleeding problems take a blood-thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others) takes more or for a longer time than directed Do not use if the child has ever had an allergic reaction to any other pain reliever / fever reducer for at least 7 days after tonsillectomy or oral surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has not been drinking fluids child has lost a lot of fluid due to vomiting and diarrhea child has high blood pressure, heart disease, lever cirrhosis, or kidney disease child is taking a diuretic child has asthma Ask a doctor or pharmacist before use if the child is taking a prescription drug for diabetes, gout or arthritis taking any other drug under a doctor’s care for any serious condition Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better pain gets worse or lasts more than 5 days any new symptoms appear redness or swelling is present in the painful area 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.

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