NDC 70518-2069 Adult Low Dose Enteric Coated Aspirin

Aspirin

NDC Product Code 70518-2069

NDC Code: 70518-2069

Proprietary Name: Adult Low Dose Enteric Coated Aspirin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspirin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
T81
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.
    • 70518-2069 - Adult Low Dose Enteric Coated Aspirin

NDC 70518-2069-0

Package Description: 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

NDC Product Information

Adult Low Dose Enteric Coated Aspirin with NDC 70518-2069 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Adult Low Dose Enteric Coated Aspirin is aspirin. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

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.

  • ASPIRIN 81 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Remedyrepack Inc.
Labeler Code: 70518
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: 05-08-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* 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

Active Ingredient (In Each Tablet)

Aspirin 81 mg(NSAID)*




*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • For the temporary relief of minor aches and painsask your doctor about other uses for aspirin

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:
  • Hivesfacial swellingasthma (wheezing)shockStomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
  • Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.
  • Ask a doctor before use ifthe stomach bleeding warning applies to youyou are taking a diureticyou have a history of stomach problems, such as heartburnyou have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthmaAsk a doctor or pharmacist before use if you aretaking any other drug containing an NSAID (prescription or nonprescription)taking a blood thinning (anticoagulant) or steroid drugtaking a prescription drug for diabetes, gout or arthritisStop use and ask a doctor ifyou 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 betteran allergic reaction occurs. Seek medical help right awaypain gets worse or lasts more than 10 daysredness or swelling is presentfever gets worse or lasts more than 3 daysany new symptoms occurringing in the ears or loss of hearing occursIf 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.

Otc - 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.

Directions

  • Drink a full glass of water with each doseswallow whole, do not chew or crushdo not exceed recommended doseadults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctorchildren under 12 years: ask a doctor

Other Information

  • Store at controlled room temperature

Inactive Ingredients

Anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum




lake, hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

* Please review the disclaimer below.

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