Naus-ease

Meclizine Hydrochloride

Sunascen Therapeutics Llc
Human Otc Drug
NDC 49467-124

Naus-ease also known as Meclizine Hydrochloride is a human otc drug labeled by 'Sunascen Therapeutics Llc'. National Drug Code (NDC) number for Naus-ease is 49467-124. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Naus-ease drug includes Meclizine Hydrochloride - 25 mg/1 . The currest status of Naus-ease drug is Active.

Drug Information:

Drug NDC:	49467-124
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:	Naus-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 Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Sunascen Therapeutics Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	ANDA
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:	16 Apr, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	12 Jun, 2026
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:	ANDA040659
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, 2024
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:	Sunascen Therapeutics LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	995666 1372663
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:	0349467124080
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
49467-124-08	1 BLISTER PACK in 1 CARTON (49467-124-08) / 8 TABLET in 1 BLISTER PACK	16 Apr, 2012	N/A	No
49467-124-16	2 BLISTER PACK in 1 CARTON (49467-124-16) / 8 TABLET in 1 BLISTER PACK	16 Apr, 2012	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.

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Purpose:

Purpose antiemetic

Product Elements:

Naus-ease meclizine hydrochloride silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate cellulose, microcrystalline d&c yellow no. 10 aluminum oxide meclizine hydrochloride meclizine tl121

Drug Interactions:

Drug interactions there may be increased cns depression when meclizine hydrochloride, usp is administered concurrently with other cns depressants, including alcohol, tranquilizers and sedatives. (see warnings ) based on in vitro evaluation, meclizine hydrochloride, usp is metabolized by cyp2d6. therefore there is a possibility for a drug interaction between meclizine hydrochloride, usp and cyp2d6 inhibitors.

Indications and Usage:

Indications and usage for consumers (the general public): naus-easeÂ® (meclizine hydrochloride), usp tablets are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness. for health professionals: based on a review of meclizine hydrochloride, usp drug by the national academy of sciences â national research council and/or other information, fda has classified the indications of meclizine hydrochloride, usp as follows: 1. the prevention and treatment (management) of nausea and vomiting, and dizziness associated with motion sickness. 2. for the treatment of vertigo.

Warnings:

Warnings clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor. due to its potential anticholinergic action, do not take unless directed by a doctor if you have a breathing problem such as asthma, emphysema, or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland. ask a doctor before use if you are taking sedatives or tranquilizers. when using this product: 1. do not exceed the recommended dosage. 2. may cause drowsiness. 3. patients should avoid alcoholic beverages while taking this drug. 4. since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. therefore patients are reminded caution when driving or operating machinery. 5. alcohol, sedatives and tranquilizers may inc Read more...

rease drowsiness. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, seek medical help or contact a poison control center right away. call poison control at 1-800-222-1222

Dosage and Administration:

Dosage and administration (directions) adults and children 12 years of age and over: take 1 to 2 naus-easeÂ® (meclizine hydrochloride), usp tablets (25 mg to 50 mg) by mouth once daily, or as directed by a physician. the initial dose of 25 mg to 50 mg of naus-easeÂ® (meclizine hydrochloride), usp tablets should be taken one hour prior to travel for the prevention and treatment of motion sickness. thereafter, the dose may be repeated every 24 hours for the duration of the journey.

Contraindications:

Contraindications meclizine hydrochloride, usp is contraindicated in individuals who have shown a previous hypersensitivity to it.

Adverse Reactions:

Adverse reactions anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

Drug Interactions:

Use in Pregnancy:

Pregnancy use pregnancy category b. reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. epidemiological studies in pregnant women, however, do not indicate that meclizine hydrochloride, usp increases the risk of abnormalities when administered during pregnancy. despite the animal findings, it would appear that the possibility of fetal harm is remote. nevertheless, meclizine hydrochloride, usp or any other medication, should be used during pregnancy only if clearly necessary, and after speaking with a health professional.

Pediatric Use:

Pediatric use clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.

Description:

Description chemically, meclizine hydrochloride, usp is 1-( p -chloro-Î±-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. meclizine hydrochloride, usp is an oral antiemetic, which is a white to slightly yellowish crystalline powder having a slight odor and is tasteless. the molecular weight is 481.89 g/mol. it has the following structural formula: c 25 h 27 cin 2 Â·2hclÂ·h 2 0 m.w. 481.88544 g/mol meclizine hydrochloride, usp structural formula

Clinical Pharmacology:

Clinical pharmacology meclizine hydrochloride, usp is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. it has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. pharmacokinetics the available pharmacokinetic information for meclizine hydrochloride, usp following oral administration has been summarized from published literature. absorption meclizine hydrochloride, usp is absorbed after oral administration with maximum plasma concentrations reaching at a median t max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. distribution drug distribution characteristics for meclizine hydrochloride, usp in humans remains unknown. metabolism the metabolic fate of meclizine hydrochlori Read more...

de, usp in humans is unknown. in an in vitro metabolic study using human hepatic microsome and recombinant cyp enzyme, cyp 2d6 was found to be the dominant enzyme for metabolism of meclizine hydrochloride, usp. the genetic polymorphism of cyp2d6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine hydrochloride, usp exposure. elimination meclizine hydrochloride, usp has a plasma elimination half-life of about 5-6 hours in humans.

Pharmacokinetics:

Pharmacokinetics the available pharmacokinetic information for meclizine hydrochloride, usp following oral administration has been summarized from published literature.

How Supplied:

How supplied naus-easeÂ® (meclizine hydrochloride), usp tablets are available in 25mg strengths, and is available in 8 and 16 count package sizes. 25 mg tablets; yellow; oval shaped; scored; "tl121" imprinted on each tablet naus-easeÂ® (meclizine hydrochloride), usp; 8 tablets: ndc 49467-124-08 naus-easeÂ® (meclizine hydrochloride), usp; 16 tablets: ndc 49467-124-16 distributed by: sunascen therapeutics llc rockville, md 20850 usa

Package Label Principal Display Panel:

Principal display panel naus-easeÂ® (meclizine hydrochloride), usp; tablets 25 mg each antiemetic â prevent and treat: nausea and vomiting tamper evident: do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering. naus-easeÂ® (meclizine hydrochloride), usp - tablet carton image

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.