NDC 70518-1949 Regular Strength Enteric Coated Aspirin

Aspirin

NDC Product Code 70518-1949

NDC Code: 70518-1949

Proprietary Name: Regular Strength Enteric Coated Aspirin Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
44;227
Score: 1

Code Structure
  • 70518 - Remedyrepack Inc.
    • 70518-1949 - Regular Strength Enteric Coated Aspirin

NDC 70518-1949-0

Package Description: 30 POUCH in 1 BOX, UNIT-DOSE > 1 TABLET, COATED in 1 POUCH (70518-1949-1)

NDC 70518-1949-2

Package Description: 30 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Regular Strength Enteric Coated Aspirin with NDC 70518-1949 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Regular Strength Enteric Coated Aspirin is aspirin. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Remedyrepack Inc.

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 Additional informationCallout TooltipWhat 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.


Regular Strength Enteric Coated Aspirin Active Ingredient(s)

Additional informationCallout TooltipWhat 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 325 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-12-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Regular Strength Enteric Coated Aspirin Product Label Images

Regular Strength 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 325 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 directedDo not use if you 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 crush
  • Do not exceed recommended doseadults
  • And children 12 years and older: take 1-2 tablets every 4 hours, as
  • Needed, not more than 12 tablets in 24 hours, or as directed by a doctorchildren under 12 years: ask a doctor

Other Information

  • Store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)for institutional use only

Inactive Ingredients

Cellulose, D&C yellow




#10 lake, FD&C yellow #6 lake, hypromellose, iron




oxide, PEG, polydextrose, polyvinyl acetate phthalate,




propylene glycol, shellac wax, silica, simethicone,




sodium alginate, sodium bicarbonate, starch, stearic




acid, talc, titanium dioxide, triacetin, triethyl citrate.




May also contain acetylated monoglycerides,




croscarmellose sodium, hypromellose phthalate,




methacrylic acid, mineral oil, polysorbate 80, sodium




lauryl sulfate.

* Please review the disclaimer below.

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