NDC 71610-528 Meclizine Hcl

Meclizine Hcl 25mg Chewable Tablets

NDC Product Code 71610-528

NDC CODE: 71610-528

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 Hcl 25mg Chewable Tablets 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
AP;115
Score: 2
Flavor(s):
RASPBERRY (C73413)

NDC Code Structure

NDC 71610-528-30

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE

NDC 71610-528-60

Package Description: 90 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Meclizine Hcl with NDC 71610-528 is a a human over the counter drug product labeled by Aphena Pharma Solutions - Tennessee, Llc. The generic name of Meclizine Hcl is meclizine hcl 25mg chewable tablets. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Aphena Pharma Solutions - Tennessee, Llc

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.

  • MECLIZINE HYDROCHLORIDE 25 mg/1

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)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • RASPBERRY (UNII: 4N14V5R27W)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SUCROSE (UNII: C151H8M554)

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: Aphena Pharma Solutions - Tennessee, Llc
Labeler Code: 71610
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: 05-01-2015 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 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

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

  • Ask a doctor before use if you haveglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an elarged prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this productyou may get drowsyavoid alcoholic drinksalcohol, sedatives and tranquilizers may increse drowsinessbe careful when driving a moor vehicle or operating machinery

Directions

  • Take dose one hour before travel startstablets can be chewed or swallowed whole with wateradults & children 12 years and over:take 1-2 tablets once dailychildren under 12 years:ask a doctor

Keep Out Of Reach Of Children.

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

Other Information

Phenylketonurics:


each tablet contains:


phenylalanine 0.28 mg


store at room temparature 15 - 30 °C

Inactive Ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:Count25 mg3071610-0528-309071610-0528-60Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.Repackaged by:Cookeville, TN 3850620210415JH

* Please review the disclaimer below.