NDC 47682-481 Medique Medi-meclizine

Meclizine Hcl

NDC Product Code 47682-481

NDC CODE: 47682-481

Proprietary Name: Medique Medi-meclizine 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):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
44;403
Score: 1

NDC Code Structure

NDC 47682-481-15

Package Description: 500 PACKET in 1 BOX > 2 TABLET in 1 PACKET

NDC 47682-481-33

Package Description: 50 PACKET in 1 BOX > 2 TABLET in 1 PACKET

NDC 47682-481-99

Package Description: 2 TABLET in 1 PACKET

NDC Product Information

Medique Medi-meclizine with NDC 47682-481 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medique Medi-meclizine is meclizine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Medique Medi-meclizine 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 12-14-2020 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.

Medique Medi-meclizine Product Label Images

Medique Medi-meclizine 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

Otc - Active Ingredient

Active ingredient (in each tablet)Meclizine HCl 25 mg

Otc - Purpose

PurposeAntiemetic

Indications & Usage

Usesfor the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Warnings

WarningsDo not use for children under 12 years of age unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use if you have■ difficulty in urination due to enlargement of the prostate gland■ glaucoma■ a breathing problems such as emphysema or chronic bronchitis

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■ drowsiness may occur■ avoid alcoholic beverages■ alcohol, sedatives and tranquilizers may increase drowsiness■ 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. In case of overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Dosage & Administration

Directions■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity■ to treat motion sickness, take at first signs of symptomsAdults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.

Other Safety Information

Other information■ tamper-evident sealed packets■ do not use any opened or torn packets■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)■ protect from heat and humidity■ use by expiration date on packet

Inactive Ingredient

Inactive ingredientscorn starch, D&C yellow # 10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Otc - Questions

Questions or comments? 1-800-634-7680

Medique Medi-Meclizine Label

Medique®Medi-MeclizineAll Day ReliefAlivio que Perdura Todo el DiaPull to OpenTire Para AbrirFor the Prevention and Treatment of Motion Sickness • Meclizine HCl 25mgPara la Prevencion y el Tratamiento del Mareo “Mal del Viajero” • Hidrochloruro de Meclizina 25mg100 Tablets(50 x 2)Tamper Evident Unit Dose PacketsEmpaquetado con Sellado Evidente en Dosis Unitarias

* Please review the disclaimer below.