NDC 72189-274 Adult Low Dose Enteric Coated Aspirin

Adult Low Dose Enteric Coated Aspirin

NDC Product Code 72189-274

NDC 72189-274-60

Package Description: 60 TABLET, COATED in 1 BOTTLE

NDC Product Information

Adult Low Dose Enteric Coated Aspirin with NDC 72189-274 is a a human over the counter drug product labeled by Direct Rx. The generic name of Adult Low Dose Enteric Coated Aspirin is adult low dose enteric coated aspirin. The product's dosage form is tablet, coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 212033 and 308416.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Adult Low Dose Enteric Coated Aspirin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct Rx
Labeler Code: 72189
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-13-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Adult Low Dose Enteric Coated Aspirin Product Label Images

Adult Low Dose Enteric Coated Aspirin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Aspirin 81mg (NSAID)**nonsteroidal anti-inflammatory drug

Otc - Purpose

Pain Reliever

Otc - When Using

For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.

ask your doctor about other uses for this product

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

asthma (wheezing)

facial swelling

shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare age 60 or older

have had stomach ulcers or bleeding problems

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 useif you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducerAsk a doctor before use ifthe 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 have asthma

you are taking a diuretic
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: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

allergic reaction occurs

pain gets worse or lasts more than 10 days

redness or swelling is present

any new symptoms occur

ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.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 accidental overdose, get medical help or contact a Poison Control Center right away.

Otc - Questions

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 persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician

children under 12 years: consult a physician

(866) 562-2756

Other Safety Information

Tamper Evident: Do not use if safety seal under cap is broken or missing

store at room temperature (15°-30°C)

avoid excess heat and moisture

Inactive Ingredient

Croscarmellose sodium, D&C yellow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

* Please review the disclaimer below.