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Low dose aspirin - Medication Information

Product NDC Code 71205-112
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 M013
Labeler Name Proficient Rx LP
Packages
Package NDC Code Description
71205-112-10 10 tablet, coated in 1 bottle, plastic (71205-112-10)
71205-112-30 30 tablet, coated in 1 bottle, plastic (71205-112-30)
71205-112-60 60 tablet, coated in 1 bottle, plastic (71205-112-60)
71205-112-72 120 tablet, coated in 1 bottle, plastic (71205-112-72)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Aspirin 81mg (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 of 12 years and over, take 4-8 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, carnuba 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, 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 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.
LOW DOSE ASPIRIN ASPIRIN ASPIRIN ASPIRIN CARNAUBA WAX SILICON DIOXIDE D&C YELLOW NO. 10 FERRIC OXIDE YELLOW METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYSORBATE 80 DIMETHICONE SODIUM LAURYL SULFATE STARCH, CORN TALC TITANIUM DIOXIDE TRIETHYL CITRATE HEART

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 71205-112-30

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

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 Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

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 bleeding problems Take a blood thinning (anticoagulant) or steroid drug Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

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