NDC 73678-160 Biovanta Double Action

Acetylsalicylic Acid

NDC Product Code 73678-160

NDC 73678-160-02

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 5 mL in 1 BOTTLE, SPRAY

NDC Product Information

Biovanta Double Action with NDC 73678-160 is a a human over the counter drug product labeled by Applied Biological Laboratories Inc.. The generic name of Biovanta Double Action is acetylsalicylic acid. The product's dosage form is spray and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2393784.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Biovanta Double Action 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE (UNII: V5VD430YW9)
  • SORBIC ACID (UNII: X045WJ989B)
  • MENTHOL (UNII: L7T10EIP3A)
  • LACTOFERRIN, BOVINE (UNII: KG21X1090A)
  • LYSOZYME (UNII: 968JKA7T33)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Applied Biological Laboratories Inc.
Labeler Code: 73678
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 08-15-2020 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.

Biovanta Double Action 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

Acetyl Salicylic Acid (NSAID) 6mg
nonsteroidal anti-inflammatory drug

Otc - Purpose

Analgesic

Uses

For the temporary relief of minor aches and pains associated with a sore throat.

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 the user:
  • Has had stomach ulcers or bleeding problemstakes a blood thinning (anticoagulant) or steroid drugtakes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)takes more or for a longer time than directed is age 60 or olderhas 3 or more alcoholic drinks every day while using this product

Pregnancy

If pregnant or breast-feeding, always ask your healthcare provider before use.

Do Not Use

  • Do not use:if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems, unless directed by a doctorIf allergic to milk and/or egg white, or have ever had an allergic reaction to this product or any of its ingredients.A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult your healthcare provider.

Keep Out Of Reach Of Children

Children Warning: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Apply one spray of Step1 and one spray of Step2 to the affected area every thirty minutes or as needed.Allow to remain in place for at least 15 seconds.Once mixed, do not use after 90 days.

Other Information

■ Store at room temperature.

■ Check unmixed product expiration date. Once mixed, fill in activation date on spray label watermark area. Do not use after 90 days after activation.


Tamper Evident: Do not use if imprinted shrink band is broken or missing.

Inactive Ingredients

Aloe, Ethanol, Glycerin, Lactoferrin, Lysozyme, Menthol, Propylene Glycol, Sodium Chloride, Sorbic Acid, Water

* Please review the disclaimer below.