NDC 11822-0775 Less Drowsy Motion Sickness Relief

Meclizine Hcl

NDC Product Code 11822-0775

NDC Code: 11822-0775

Proprietary Name: Less Drowsy Motion Sickness Relief 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):
10 MM
Imprint(s):
44;403
Score: 1

NDC Code Structure

  • 11822 - Rite Aid Corporation
    • 11822-0775 - Less Drowsy Motion Sickness Relief

NDC 11822-0775-3

Package Description: 10 TABLET in 1 VIAL, PLASTIC

NDC 11822-0775-9

Package Description: 1 BLISTER PACK in 1 CARTON > 8 TABLET in 1 BLISTER PACK

NDC Product Information

Less Drowsy Motion Sickness Relief with NDC 11822-0775 is a a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Less Drowsy Motion Sickness Relief is meclizine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Rite 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.

Less Drowsy Motion Sickness Relief 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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • 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: Rite Aid Corporation
Labeler Code: 11822
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: 06-30-2019 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.This medication is ...
[Read More]

* Please review the disclaimer below.

Less Drowsy Motion Sickness Relief 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

Active Ingredient (In Each Tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

  • For prevention and treatment of these symptoms associated with motion sickness:nauseavomitingdizziness

Do Not Use

For children under 12 years of age unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Glaucomadifficulty in urination due to an enlargement of the prostate glanda breathing problems such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranqulizers

When Using This Product

  • Drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful 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 a Poison Control Center right away.

Directions

  • To prevent motion sickness, take the fitst dose one hour before starting activityto prevent or treat motion sickness: 1 to 2 tablets once daily for adults and children 12 years and over, or as directed by a doctor

Other Information

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)protect from heat and humidityused by expiration date on package

Inactive Ingredients

Corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gel

* Please review the disclaimer below.

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