NDC 65197-296 Bonine

Meclizine Hydrochloride

NDC Product Code 65197-296

NDC CODE: 65197-296

Proprietary Name: Bonine 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: Meclizine Hydrochloride 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):
PINK (C48328 - LIGHT PINK)
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
BONINE;201
Score: 2
Flavor(s):
RASPBERRY (C73413)
VANILLA (C73421)

NDC Code Structure

NDC 65197-296-08

Package Description: 1 BLISTER PACK in 1 BOX > 8 TABLET, CHEWABLE in 1 BLISTER PACK

NDC 65197-296-12

Package Description: 1 BOTTLE in 1 BOX > 12 TABLET, CHEWABLE in 1 BOTTLE

NDC 65197-296-16

Package Description: 2 BLISTER PACK in 1 BOX > 8 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Bonine with NDC 65197-296 is a a human over the counter drug product labeled by Wellspring Pharmaceutical Corporation. The generic name of Bonine is meclizine hydrochloride. The product's dosage form is tablet, chewable and is administered via oral form.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Bonine 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.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Wellspring Pharmaceutical Corporation
Labeler Code: 65197
FDA Application Number: part336 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: 08-26-2021 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.

Information for Patients

Meclizine

Meclizine is pronounced as (mek' li zeen)

Why is meclizine medication prescribed?
Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.This medication is ...
[Read More]

* Please review the disclaimer below.

Bonine 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 Ingredient (In Each Tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

Directions

  • Dosage should be taken one hour before travel startsadults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

Other Information

Store at room temperature 20°– 25°C (68°–77°F)

Inactive Ingredients

Croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.

Questions?

Call toll-free 1 (844) 241-5454 or visit us on the web at www.bonine.com

* Please review the disclaimer below.