Dramamine
Dimenhydrinate
Mechanical Servants, Llc
Human Otc Drug
NDC 29485-6925Dramamine also known as Dimenhydrinate is a human otc drug labeled by 'Mechanical Servants, Llc'. National Drug Code (NDC) number for Dramamine is 29485-6925. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Dramamine drug includes Dimenhydrinate - 50 mg/1 . The currest status of Dramamine drug is Active.
Drug Information:
| Drug NDC: | 29485-6925 |
| 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: | Dramamine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Mechanical Servants, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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: | 06 Feb, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Mechanical Servants, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309913
602223
|
| 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. |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 29485-6925-3 | 3 POUCH in 1 BLISTER PACK (29485-6925-3) / 2 TABLET, CHEWABLE in 1 POUCH | 06 Feb, 2017 | N/A | 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 antiemetic
Product Elements:
Dramamine dimenhydrinate fd&c yellow no. 6 aluminum oxide maltodextrin methacrylic acid - methyl methacrylate copolymer (1:1) sorbitol aspartame dimenhydrinate chlortheophylline anhydrous citric acid magnesium stearate starch, corn dra dramamine dimenhydrinate fd&c yellow no. 6 aluminum oxide maltodextrin methacrylic acid - methyl methacrylate copolymer (1:1) sorbitol aspartame starch, corn dimenhydrinate chlortheophylline anhydrous citric acid magnesium stearate dra dramamine dimenhydrinate fd&c yellow no. 6 aluminum oxide maltodextrin methacrylic acid - methyl methacrylate copolymer (1:1) sorbitol aspartame dimenhydrinate chlortheophylline anhydrous citric acid magnesium stearate starch, corn dra
Indications and Usage:
Use for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness
Warnings:
Warnings do not use for children under 2 years of age unless directed by a doctor ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery if pregnant or breast-feeding, ask a doctor before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings do not use for children under 2 years of age unless directed by a doctor ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery if pregnant or breast-feeding, ask a doctor before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over take 1 to 2 chewable tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor children 6 to under 12 years give 1/2 to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor children 2 to under 6 years give 1/2 chewable tablet every 6-8 hours do not give more that 1 1/2 chewable tablets in 24 hours, or as directed by a doctor
Package Label Principal Display Panel:
Principal display panel - 50mg tablet pouch blister #1 pharmacist recommended brand dimenhydrinate tablets/antiemetic dramamine ® motion sickness chewable dual action: prevents & relieves nausea, dizziness and vomiting 4 orange flavored tablets (50 mg each) pdp
Principal display panel - 50mg tablet pouch blister #1 pharmacist recommended brand dimenhydrinate tablets/antiemetic dramamine ® motion sickness chewable dual action: prevents & relieves nausea, dizziness and vomiting 6 orange flavored tablets (50 mg each) dramamine 6ct
Principal display panel - 50mg tablet pouch box #1 pharmacist recommended brand dimenhydrinate tablets/antiemetic dramamine ® motion sickness chewable dual action: prevents & relieves nausea, dizziness and vomiting 25 pouches 2 orange flavored tablets (50 mg each) per pouch pdp
Further Questions:
Questions? 1-800-382-7219 dramamine.com