NDC 71610-528 Meclizine Hcl
Meclizine Hcl 25mg Chewable Tablets Tablet, Chewable Oral

Product Information

Product Code71610-528
Proprietary Name 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.
Meclizine Hcl
Non-Proprietary Name 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.
Meclizine Hcl 25mg Chewable Tablets
Product Type 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.
Human Otc Drug
Dosage FormTablet, 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.
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.
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code71610
FDA Application Number 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.
part336
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-01-2015
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)RED (C48326)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)AP;115
Score2
Flavor(s)RASPBERRY (C73413)

Product Packages

NDC 71610-528-30

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE

NDC 71610-528-60

Package Description: 90 TABLET, CHEWABLE in 1 BOTTLE

Product Details

Meclizine Hcl is 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.


What are Meclizine Hcl Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Meclizine Hcl Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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 have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an elarged prostate gland
  • Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increse drowsiness
    • be careful when driving a moor vehicle or operating machinery

Directions



take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

  • take 1-2 tablets once daily
  • children 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


Questions Or Comments



Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


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 mg
3071610-0528-30
9071610-0528-60

Store 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 38506

20210415JH


Principal Display Panel - 25 Mg



NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets


* Please review the disclaimer below.