NDC 70985-010 Meclizine Hcl

Meclizine Hydrochloride Chewable

NDC Product Code 70985-010

NDC CODE: 70985-010

Proprietary Name: Meclizine Hcl 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 Chewable 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.

  • Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems.

Product Characteristics

Color(s):
PINK (C48328 - PINK TO LIGHT PINK)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
M
Score: 2
Flavor(s):
RASPBERRY (C73413)

NDC Code Structure

  • 70985 - Drug Ocean Llc

NDC 70985-010-01

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Meclizine Hcl with NDC 70985-010 is a a human over the counter drug product labeled by Drug Ocean Llc. The generic name of Meclizine Hcl is meclizine hydrochloride chewable. The product's dosage form is tablet, chewable and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 995632.

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.

Meclizine Hcl 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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)
  • SUCROSE (UNII: C151H8M554)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

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: Drug Ocean Llc
Labeler Code: 70985
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: 06-25-2021 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.

Meclizine Hcl Product Label Images

Meclizine Hcl 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 Ingredients (In Each Tablet)

Meclizine HCl, USP 25 mg

Purpose

Antiemetic

Uses:

Prevents and treats nausea, vomiting, or dizziness due to motion sickness.

Warnings:

  • Do not take this product, unless directed by a doctor, if you haveGlaucomaA breathing problem such as emphysema or chronic bronchitisTrouble urinating due to an enlarged prostate gland

When Using Product

  • Do not exceed recommended dosagemay cause drowsinessalcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic drinksuse caution when driving a motor vehicle or operating machinery

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

  • Dosage should be taken one hour before travel starts adults and children 12 years and over   take 2 or 4 tablets once daily or as directed by a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients

Colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

* Please review the disclaimer below.