NDC 70518-2729 Rugby Meclizine Hcl

Meclizine Hydrochloride

NDC Product Code 70518-2729

NDC CODE: 70518-2729

Proprietary Name: Rugby 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 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):
WHITE (C48325 - FILM COATED)
Shape: CAPSULE (C48336)
Size(s):
13 MM
Imprint(s):
19G
Score: 2

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2729-0

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Rugby Meclizine Hcl with NDC 70518-2729 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Rugby Meclizine Hcl is meclizine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Rugby 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 12.5 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.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Remedyrepack Inc.
Labeler Code: 70518
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: 05-06-2020 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: 12-31-2021 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.

Rugby Meclizine Hcl Product Label Images

Rugby 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

Drug Facts

Distributed by:
Rugby Laboratories17177 N. Laurel Park Drive, Suite 233Livonia, MI 48152www.rugbylaboratories.comRepackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Otc - Active Ingredient

Active ingredient (in each caplet)Meclizine HCl, USP 12.5 mg

Otc - Purpose

PurposeAntiemetic

Indications & Usage

Usesprevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

Warnings

Otc - Do Not Use

Do not use in children under 12 years of age unless directed by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you haveglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Otc - When Using

  • When using this product​may cause drowsiness
  • Alcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic drinksuse caution when driving a motor vehicle or operating machinery

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

  • DirectionsDosage should be taken one hour before travel startsAdults and children 12 years of age and older: take 2-4 caplets 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 informationEach Caplet Contains:
  • Calcium 25 mgStore at room temperature in a dry placeKeep lid tightly closed

Inactive Ingredient

Inactive ingredients croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, titanium dioxide.

Otc - Questions

Questions or comments? Call1-800-645-2158

Other Safety Information

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

How Supplied

Meclizine HCl 12.5 mg Tablet capsule shaped, white, imprint 19G supplied in:NDC: 70518-2729-00 30 in 1 BOTTLE PLASTICRepackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

* Please review the disclaimer below.