NDC 55700-746 Aspirin 81 Mg Enteric Coated

Aspirin

NDC Product Code 55700-746

NDC Code: 55700-746

Proprietary Name: Aspirin 81 Mg Enteric Coated 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):
5 MM
Imprint(s):
HEART
Score: 1

NDC Code Structure

  • 55700 - Quality Care Products, Llc
    • 55700-746 - Aspirin 81 Mg Enteric Coated

NDC 55700-746-60

Package Description: 60 TABLET in 1 BOTTLE

NDC Product Information

Aspirin 81 Mg Enteric Coated with NDC 55700-746 is a a human over the counter drug product labeled by Quality Care Products, Llc. The generic name of Aspirin 81 Mg Enteric Coated is aspirin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Quality Care Products, Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Aspirin 81 Mg Enteric Coated 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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • TALC (UNII: 7SEV7J4R1U)
  • IRON (UNII: E1UOL152H7)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Quality Care Products, Llc
Labeler Code: 55700
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: 04-26-2019 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.

Aspirin 81 Mg Enteric Coated Product Label Images

Aspirin 81 Mg Enteric Coated 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 Ingredients (In Each Tablet)

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

Purpose

Pain reliever

Uses

  • Temporarily relieves minor aches and painsBecause 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

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 symptons could be an early sign of Reye's syndrome, a rare but serious illness.

Other Safety Information

  • Allergy alert: Aspirin may cause a severe allergic reaction, which any include:
  • Hives facial swellingshockasthma (wheezing)

Other

  • Somach bleeding warning: This product contains 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 steriod 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

Otc - Do Not Use

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Otc - Ask Doctor

  • Ask a doctor before use if stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have not been dirinking fluidsyou have lost a lot of fluid due to vomiting or diarrhea

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking a prescription drug for diabetes, gout, or arthritistaking any other drugunder a doctor's care for any serious condition

Otc - Stop Use

  • Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding: feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betterpain gets worse or lasts more than 10 daysredness or swelling is presentnew symptoms occurringing in the ears or a loss of hearing occursThese could be sings of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or brest-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 conplications 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 doseadults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctorchildren under 12 years: consult a doctor

Other Information

  • Store at 25ºC (77ºF) excursions permitted between 15º-30ºC (59º-86ºF)use by expiration date on package

Inactive Ingredients

Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

* Please review the disclaimer below.

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