NDC 73678-360 Biovanta Trip Action Lemon And Honey

Acetylsalicylic Acid, Menthol

NDC Product Code 73678-360

NDC CODE: 73678-360

Proprietary Name: Biovanta Trip Action Lemon And Honey 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: Acetylsalicylic Acid, Menthol 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):
17 MM
Score: 1
Flavor(s):
LEMON (C73396)
HONEY (C73394)

NDC Code Structure

  • 73678 - Applied Biological Laboratories Inc.
    • 73678-360 - Biovanta Trip Action Lemon And Honey

NDC 73678-360-24

Package Description: 24 BLISTER PACK in 1 BOX > 1 LOZENGE in 1 BLISTER PACK

NDC Product Information

Biovanta Trip Action Lemon And Honey with NDC 73678-360 is a a human over the counter drug product labeled by Applied Biological Laboratories Inc.. The generic name of Biovanta Trip Action Lemon And Honey is acetylsalicylic acid, menthol. The product's dosage form is lozenge and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2394061.

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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 Trip Action Lemon And Honey 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.

  • ISOMALT (UNII: S870P55O2W)
  • HONEY (UNII: Y9H1V576FH)
  • LACTOFERRIN, BOVINE (UNII: KG21X1090A)
  • LYSOZYME (UNII: 968JKA7T33)
  • ALOE (UNII: V5VD430YW9)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)
  • STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)

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: part341 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: 08-01-2020 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 Trip Action Lemon And Honey Product Label Images

Biovanta Trip Action Lemon And Honey 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

Drug Facts

Drug Facts

Active Ingredient (In Each Lozenge):

Menthol 5mg......AntitussiveAcetyl Salicylic Acid* (NSAID)* 6 mg.......Analgesic*nonsteroidal anti-inflammatory drug

Purpose

Antitussive and Analgesic

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

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 ■ ShockStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user:■ hashad stomach ulcers or bleeding problems

■ takes a blood thinning (anticoagulant) or steroid drug

■ takes other drugs containing prescription or nonprescription NSAl□s (e.g. aspirin, ibuprofen, naproxen, or others)

■ takes more than directed or for a longer time than directed

■ is age60 or older

■ has 3 or more alcoholic drinks per day while using this product

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.

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

Pregnancy: 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.

Keep Out Of The 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

• Dissolve1 lozenge slowly in mouth.

• Repeat every half hour as needed or as directed by health care provider.

• Children under 6 consult health care provider.

Other Information

■ Store at room temperature.

■ Check expiration date before using.

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

■ Do not give lozenges to children younger than age 4.

Inactive Ingredients

Aloe, Honey, lsomalt, Lactoferin, Lysozyme, Natural Colors, Natural Lemon Flavor, Stevia Rebaudiana, Sodium Chloride, Water

Biovanta Lemon & Honey

Bio vanta™(NSAID*)TRIPLE ACTIONSOOTHES SORE THROATS.FIGHTS COLDS & COUGH.Natural Bioactive IngredientsLemon & Honey24 LozengesNDC 73678-360-24Distributed by:Applied Biological Laboratories760 Parkside Ave.317, 327-D and 327-FBrooklyn, New York 11226

* Please review the disclaimer below.