Biovanta Trip Action Lemon And Honey

Acetylsalicylic Acid, Menthol


Applied Biological Laboratories Inc.
Human Otc Drug
NDC 73678-360
Biovanta Trip Action Lemon And Honey also known as Acetylsalicylic Acid, Menthol is a human otc drug labeled by 'Applied Biological Laboratories Inc.'. National Drug Code (NDC) number for Biovanta Trip Action Lemon And Honey is 73678-360. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Biovanta Trip Action Lemon And Honey drug includes Aspirin - 6 mg/1 Menthol - 5 mg/1 . The currest status of Biovanta Trip Action Lemon And Honey drug is Active.

Drug Information:

Drug NDC: 73678-360
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Biovanta Trip Action Lemon And Honey
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Acetylsalicylic Acid, Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Applied Biological Laboratories Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Lozenge
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ASPIRIN - 6 mg/1
MENTHOL - 5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 01 Aug, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 06 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part341
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.
Listing Expiration Date: 31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Applied Biological Laboratories Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:2394061
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000000160
N0000008836
M0001335
N0000175722
N0000175578
N0000008832
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:R16CO5Y76E
L7T10EIP3A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Cyclooxygenase Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Decreased Prostaglandin Production [PE]
Decreased Platelet Aggregation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Anti-Inflammatory Agents, Non-Steroidal [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Decreased Platelet Aggregation [PE]
Decreased Prostaglandin Production [PE]
Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
73678-360-044 BLISTER PACK in 1 BOX (73678-360-04) / 1 LOZENGE in 1 BLISTER PACK01 Feb, 2023N/ANo
73678-360-1212 BLISTER PACK in 1 BOX (73678-360-12) / 1 LOZENGE in 1 BLISTER PACK01 Feb, 2023N/ANo
73678-360-2424 BLISTER PACK in 1 BOX (73678-360-24) / 1 LOZENGE in 1 BLISTER PACK01 Aug, 2020N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose antitussive and analgesic

Product Elements:

Biovanta trip action lemon and honey acetylsalicylic acid, menthol isomalt honey lactoferrin, bovine lysozyme aloe sodium chloride water stevia rebaudiana whole aspirin aspirin menthol menthol

Indications and Usage:

Uses ■ temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. ■ for the temporary relief of minor aches and pains associated with a sore throat.

Warnings:

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: ■ asthma (wheezing) ■ hives ■ facial swelling ■ shock stomach 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 problems ■ takes a blood thinning (anticoagulant) or steroid drug ■ takes other drugs containing prescription or nonprescription nsalds (e.g. aspirin, ibuprofen, naproxen, or others) ■ takes more than directed or for a longer time than directed ■ is age 60 or older ■ has 3 or more alcoholic drinks per day while
using this product ask a doctor before use ask a doctor before use if you have: ■ a history of stomach problems, such as heartburn ■ high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ not been drinking fluids ■ lost a lot of fluid due to vomiting or diarrhea stop use stop use of this product and ask a healthcare provider if user experiences any of the lollowing signs or stomach bleeding: feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better pregnancy: if pregnant or breast-feeding if pregnant or breast-feeding always ask your healthcare provider before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor as it may cause problems in the unborn child or complications during delivery. 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 doctor. if 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 the 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.

Do Not Use:

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: ■ asthma (wheezing) ■ hives ■ facial swelling ■ shock stomach 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 problems ■ takes a blood thinning (anticoagulant) or steroid drug ■ takes other drugs containing prescription or nonprescription nsalds (e.g. aspirin, ibuprofen, naproxen, or others) ■ takes more than directed or for a longer time than directed ■ is age 60 or older ■ has 3 or more alcoholic drinks per day while using this product ask a doctor before use ask a doctor before use if you have: ■ a history of stomach problems, such as heartburn ■ high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ not been drinking fluids ■ lost a lot of fluid due to vomiting or diarrhea stop use stop use of this product and ask a healthcare provider if user experiences any of the lollowing signs or stomach bleeding: feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better pregnancy: if pregnant or breast-feeding if pregnant or breast-feeding always ask your healthcare provider before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor as it may cause problems in the unborn child or complications during delivery. 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 doctor. if 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 the 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.

Dosage and Administration:

Directions • dissolve1 lozenge slowly in mouth. • repeat every 30 minutes as needed or as directed by health care provider. • children under 6 consult health care provider.

Stop Use:

Stop use stop use of this product and ask a healthcare provider if user experiences any of the lollowing signs or stomach bleeding: feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better

Package Label Principal Display Panel:

Label


Comments/ Reviews:

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