NDC 70518-3015 Meclizine Hydrochloride

Meclizine Hydrochloride

NDC Product Code 70518-3015

NDC CODE: 70518-3015

Proprietary Name: Meclizine Hydrochloride 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):
PINK (C48328 - ROSY)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
5172
Score: 2
Flavor(s):
VANILLA (C73421)
RASPBERRY (C73413)

NDC Code Structure

NDC 70518-3015-0

Package Description: 10 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 70518-3015-1

Package Description: 30 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Meclizine Hydrochloride with NDC 70518-3015 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Meclizine Hydrochloride is meclizine hydrochloride. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Remedyrepack Inc.

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 Hydrochloride 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.

  • CROSPOVIDONE (UNII: 2S7830E561)
  • VANILLA (UNII: Q74T35078H)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • RASPBERRY (UNII: 4N14V5R27W)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 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: 02-03-2021 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 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.

Meclizine Hydrochloride Product Label Images

Meclizine Hydrochloride 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

Drug Facts

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

Otc - Purpose

Purpose
Antiemetic

Uses

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

Do Not Use In

Children under 12 years of age unless directed by a doctor

Ask A Doctor Before Use If You Have

 glaucoma a breathing problem such as emphysema or chronic bronchitis




 trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If

You are taking sedatives or tranquilizers

When Using This Product

 Do not exceed recommended dosage may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks




 use 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.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

 Dosage should be taken one hour before travel startsadults and children 12




years of age and over



chew 1 to 2 tablets once daily, or as directed by a doctorchildren under




12 years of age



do not give this product to children under 12 years of age




unless directed by a doctor

Other Information

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium store at room temperature in a dry place keep lid tightly closed

Inactive Ingredient

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Other

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDRENTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

* Please review the disclaimer below.