Travel Ease
Meclizine Hcl
Chain Drug Marketing Association Inc
Human Otc Drug
NDC 63868-163Travel Ease also known as Meclizine Hcl is a human otc drug labeled by 'Chain Drug Marketing Association Inc'. National Drug Code (NDC) number for Travel Ease is 63868-163. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Travel Ease drug includes Meclizine Hydrochloride - 25 mg/1 . The currest status of Travel Ease drug is Active.
Drug Information:
| Drug NDC: | 63868-163 |
| 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: | Travel Ease |
| 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: | Meclizine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Chain Drug Marketing Association Inc |
| 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: | MECLIZINE HYDROCHLORIDE - 25 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: | 29 May, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | CHAIN DRUG MARKETING ASSOCIATION INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995632
|
| 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: | 0635515967076
|
| UPC stands for Universal Product Code. |
| UNII: | HDP7W44CIO
|
| 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: | Antiemetic [EPC]
Emesis Suppression [PE]
|
| 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 |
|---|
| 63868-163-16 | 2 BLISTER PACK in 1 CARTON (63868-163-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 29 May, 2002 | 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:
Travel ease meclizine hcl meclizine hydrochloride meclizine starch, corn fd&c red no. 40 anhydrous lactose magnesium stearate saccharin sodium silicon dioxide 44;404
Indications and Usage:
Uses for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
Warnings:
Warnings do not use for children under 12 years of age unless directed by a doctor. ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur avoid alcoholic beverages use caution 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 (1-800-222-1222) right away.
Do Not Use:
Warnings do not use for children under 12 years of age unless directed by a doctor. ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur avoid alcoholic beverages use caution 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 (1-800-222-1222) right away.
When Using:
When using this product alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
Package Label Principal Display Panel:
Principal display panel ndc 63868-163-16 qc quality choice® *compare to the active ingredient in bonine® chewable tablets travel ease meclizine hci 25 mg chewable tablets | antiemetic motion sickness relief prevents motion sickness up to 24 hours of protection chew or crush tablets completely before swallowing. raspberry flavored 16 tablets (25 mg each) actual size tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering *this product is not manufactured or distributed by insight pharmaceuticals llc, owner of the registered trademark bonine® chewable tablets. 50844 rev1218a40421 distributed by c.d.m.a., inc.© 43157 w 9 mile rd novi, mi 48375 www.qualitychoice.com questions: 248-449-9300 100% qc satisfaction guaranteed quality choice 44-404 quality choice 44-404
Further Questions:
Questions or comments? 1-800-426-9391