Physicianscare Dimenhydrinate Motion Sickness Relief
Dimenhydrinate
Acme United Corporation
Human Otc Drug
NDC 0924-1006Physicianscare Dimenhydrinate Motion Sickness Relief also known as Dimenhydrinate is a human otc drug labeled by 'Acme United Corporation'. National Drug Code (NDC) number for Physicianscare Dimenhydrinate Motion Sickness Relief is 0924-1006. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Physicianscare Dimenhydrinate Motion Sickness Relief drug includes Dimenhydrinate - 50 mg/1 . The currest status of Physicianscare Dimenhydrinate Motion Sickness Relief drug is Active.
Drug Information:
| Drug NDC: | 0924-1006 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Physicianscare Dimenhydrinate Motion Sickness Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Physicianscare Dimenhydrinate |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Motion Sickness Relief |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dimenhydrinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acme United Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMENHYDRINATE - 50 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 05 Oct, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2023 |
| 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. |
| Application Number: | part336 |
| 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. |
| Listing Expiration Date: | 14 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Acme United Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198603
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0738743001083
|
| UPC stands for Universal Product Code. |
| UNII: | JB937PER5C
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0924-1006-01 | 50 PACKET in 1 CARTON (0924-1006-01) / 2 TABLET, COATED in 1 PACKET | 05 Oct, 2013 | 31 Mar, 2023 | No |
| 0924-1006-02 | 6 PACKET in 1 BAG (0924-1006-02) / 2 TABLET, COATED in 1 PACKET | 05 Oct, 2013 | 31 Mar, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose purpose antiemetic
Product Elements:
Physicianscare dimenhydrinate motion sickness relief dimenhydrinate croscarmellose sodium dibasic calcium phosphate dihydrate magnesium stearate cellulose, microcrystalline dimenhydrinate diphenhydramine 1006;1006
Indications and Usage:
Uses for prevention and treatmeant of nausea, vomiting or dizziness associated with motion sickness
Warnings:
Warnings do not use for children under 2 years of age unless directed by a doctor ask doctor before use if you have â¢breathing problem such as emphysema or chronic bronchitis â¢glaucoma â¢trouble urinatining due to an enlarged prostate gland. ask doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product â¢marked drowsiness may occur â¢avoid alcoholic drinks â¢alcohol, sedatives and tranquilizers may increase drowsiness â¢be careful when driving a motor vehicle or operating machinery. if pregnant or breast feeding, ask a health professional before use. keep out of the reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product â¢marked drowsiness may occur â¢avoid alcoholic drinks â¢alcohol, sedatives and tranquilizers may increase drowsiness â¢be careful when driving a motor vehicle or operating machinery.
Dosage and Administration:
Directions t o prevent motion sickness the first dose should be taken 1/2 to 1 hour before starting activity. to prevent or treat motion sickness: adults and children: (12 years and older): take 1 -2 tablets every 4 - 6 hours, not more than 8 tablets in 24 hours, or as directed by doctor children 6 to under 12 years: give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by a doctor. children 2 to under 6 years: give ¼ to 1/2 tablet every 6 - 8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor.
Overdosage:
In case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
Carton label 50ct- carton label
Package Label Principal Display Panel:
Packet label pouch 1 pouch 2
Bag label 1006-acme label
Further Questions:
Questions? 1-800-835-2263 www.firstaidonly.com