NDC 61919-641 Meclizine Hcl

Meclizine Hcl

NDC Product Code 61919-641

NDC Code: 61919-641

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 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)
Shape: ROUND (C48348)
Size(s):
8 MM
9 MM
Imprint(s):
21G
TCL333
Score: 2
Flavor(s):
RASPBERRY (C73413)

NDC Code Structure

  • 61919 - Directrx
    • 61919-641 - Meclizine Hcl

NDC 61919-641-20

Package Description: 20 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Meclizine Hcl with NDC 61919-641 is a a human over the counter drug product labeled by Directrx. The generic name of Meclizine Hcl is meclizine hcl. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Directrx

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/251

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 (UNII: 029TFK992N)
  • SUCROSE (UNII: C151H8M554)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • RASPBERRY (UNII: 4N14V5R27W)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SACCHARIN (UNII: FST467XS7D)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • VANILLA (UNII: Q74T35078H)

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: Directrx
Labeler Code: 61919
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: 04-10-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* 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....
[Read More]

* 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

Other

Distributed by: Rugby Laboratories17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152Drug Facts

Otc - Active Ingredient

Active ingredient (in each chewable tablet)Meclizine HCl USP 25 mg

Otc - Purpose

Antiemetic

Indications & Usage

Uses prevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

WarningsDo not use in children under 12 years of age unless directed by a doctorAsk a doctor before use if you haveglaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.When using this productmay cause drowsiness

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately.

Dosage & Administration

DirectionsDosage should be taken one hour before travel starts

Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

Storage And Handling

Other informationPhenylketonurics: Contains Phenylalanine 0.28 mg per tablet

Store at room temperature in a dry place

Keep lid tightly closed

Inactive Ingredient

Aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Otc - Questions

Questions or comments?call 1-800-645-2158

Other Safety Information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Otc - Keep Out Of Reach Of Children

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

* Please review the disclaimer below.

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