NDC 73089-081 Vazalore

Aspirin

NDC Product Code 73089-081

NDC CODE: 73089-081

Proprietary Name: Vazalore 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a "blood thinner" to prevent blood clots.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE WITH BLUE BAND AND A81 IMPRINT)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
A81
Score: 1

NDC Code Structure

NDC 73089-081-12

Package Description: 1 BLISTER PACK in 1 CARTON > 81 mg in 1 BLISTER PACK

NDC 73089-081-14

Package Description: 81 mg in 1 CARTON

NDC 73089-081-21

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 81 mg in 1 BOTTLE, PLASTIC

NDC Product Information

Vazalore with NDC 73089-081 is a a human over the counter drug product labeled by Plx Pharma Inc. The generic name of Vazalore is aspirin. The product's dosage form is capsule and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 252857 and 2563431.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Vazalore 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.


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 CITRIC ACID (UNII: XF417D3PSL)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Plx Pharma Inc
Labeler Code: 73089
FDA Application Number: NDA203697 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: NDA - A product marketed under an approved New Drug Application. 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: 08-05-2021 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.

Vazalore 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

Uses

  • For temporary relief of minor aches and pains associated with:headache Backachemuscular aches a cold toothache minor pains of arthritis premenstrual and menstrual crampstemporarily redices fevern ask your doctor about other uses of aspirin capsules

Warnings

  • WarningsReye’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
  • N hives n facial wseelling n shock n astham (wheezing)This product contains soyStomach bleeding warning: This product contains an NSAID, which may cause bleeding. The chance is higher if you:
  • Are age 60 or olderHave had stomach ulcers or bleeding problemsTake 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 productTake more or for a longer time than directed

Otc - Active Ingredient

Active Ingredient (in Each capsules)Aspirin (NSAID)* 325mg*Non steroidal Anti inflammatory Drug

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 asthma

Otc - Do Not Use

Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or a pharmacist before you use if you areTaking a drug for diabetes, gout or arthritis

Stop Use And Ask A Doctor

  • Stop use and ask a doctor ifAn allergic reaction occurs. Seek medical help right awayYou experience amu of the following signs of stomach bleeding- Feel faint - vomit blood - have bloody or black stool - have stomach pain that does not get betterPain gets worse or lasts more than 10 daysFever gets worse or lasts more than 3 daysRinging in the ears or loss of hearing occursRedness and swelling is present in the painful areaAny new symptoms occur. These could be signs of serious conditions

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a healthcare 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 - Purpose

Purposes:Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer*Non steroidal Anti inflammatory Drug

Other Information

  • Other InformationSave carton for full directions and warningsStore at 15-30°C (59-86°F)Avoid excessive heat above 40°C (104°F)Do not use if the blue band around the capsule is missing or broken

Inactive Ingredient

Inactive ingredientsAnhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

Directions

  • DirectionsDrink a full glass of water with each doseAdults and children 12 years and over:
  • Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persistDo not exceed 12 capsules in 24 hoursChildren under 12 years consult a doctor

* Please review the disclaimer below.