NDC 0924-1006 Physicianscare Dimenhydrinate Motion Sickness Relief

Dimenhydrinate

NDC Product Code 0924-1006

NDC Code: 0924-1006

Proprietary Name: Physicianscare Dimenhydrinate 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: Dimenhydrinate 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 - WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
1006;1006
Score: 2

NDC Code Structure

NDC 0924-1006-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET

NDC 0924-1006-02

Package Description: 6 PACKET in 1 BAG > 2 TABLET, COATED in 1 PACKET

NDC Product Information

Physicianscare Dimenhydrinate Motion Sickness Relief with NDC 0924-1006 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicianscare Dimenhydrinate Motion Sickness Relief is dimenhydrinate. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Acme United Corporation

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Physicianscare Dimenhydrinate 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.

  • DIMENHYDRINATE 50 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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: Acme United Corporation
Labeler Code: 0924
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: 10-05-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 03-31-2023 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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’.

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Information for Patients

Dimenhydrinate

Dimenhydrinate is pronounced as (dye men hye' dri nate)

Why is dimenhydrinate medication prescribed?
Dimenhydrinate is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. Dimenhydrinate is in a class of medications called antihistamines. ...
[Read More]

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Physicianscare Dimenhydrinate Motion Sickness Relief Product Label Images

Physicianscare Dimenhydrinate 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

Otc - Active Ingredient

Active Ingredient (in each tablet)Dimenhydrinate 50 mg

Otc - Purpose

PurposeAntiemetic

Indications & Usage

  • Usesfor prevention and treatment of these symptoms associated with motion sicknessnauseavomitingdizziness

Warnings

  • WarningsDo not use for children under 2 years of age unless directed by a doctor Ask a doctor before use if you havea breathing problem  such as emphysema or chronic bronchitisglaucomatrouble urinatining due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers. When using this productmarked 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.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsto prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activityto prevent or treat motion sickness, see below:Adults and children: (12 years and older)Take 1 to 2 tablets every 4-6 hours. Do not take more than 8 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years:Give ½ to 1 tablet every 6-8 hours. Do not give more than 3 tablets in 24 hours, or as directed by a doctor.Children 2 years to under 6 years:Give 1/2 tablet every 6 to 8 hours. Do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor.

Information For Patients

  • Other Informationstore between 20-25C (68-77F)see side panel for lot number and expiration date

Inactive Ingredient

Inactive ingredientscroscarmellose sodium, magnesium stearate, microcrystalline celluslose, dicalcium phosphate

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