Cvs Health Nausea Relief

Sodium Citrate Dihydrate


Cvs Pharmacy,inc.
Human Otc Drug
NDC 69842-423
Cvs Health Nausea Relief also known as Sodium Citrate Dihydrate is a human otc drug labeled by 'Cvs Pharmacy,inc.'. National Drug Code (NDC) number for Cvs Health Nausea Relief is 69842-423. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Cvs Health Nausea Relief drug includes Trisodium Citrate Dihydrate - 230 mg/1 . The currest status of Cvs Health Nausea Relief drug is Active.

Drug Information:

Drug NDC: 69842-423
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: Cvs Health Nausea Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Cvs Health
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Nausea 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: Sodium Citrate Dihydrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cvs Pharmacy,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:TRISODIUM CITRATE DIHYDRATE - 230 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: UNAPPROVED DRUG OTHER
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: 22 May, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 18 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.
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:CVS PHARMACY,INC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:2002800
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:B22547B95K
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:Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
69842-423-423 BLISTER PACK in 1 CARTON (69842-423-42) / 14 TABLET, CHEWABLE in 1 BLISTER PACK22 May, 2019N/ANo
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 upset stomach reliever/antacid

Product Elements:

Cvs health nausea relief sodium citrate dihydrate trisodium citrate dihydrate anhydrous citric acid dextrose, unspecified form fd&c red no. 40 cherry fructose hypromellose, unspecified magnesium stearate silicon dioxide carboxymethylcellulose sodium, unspecified sucralose rp183 wild cherry flavor

Indications and Usage:

Uses for the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

Warnings:

Warnings

Do Not Use:

Warnings

When Using:

When using this product, do not take more than 24 tablets in a 24-hour period.

Dosage and Administration:

Directions ▪ adults : 2-4 tablets. ▪ children : consult a doctor for appropriate dosage. ▪ chew tablets completely. do not swallow tablet whole. ▪ dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor. ▪ read all package directions and warning before use and use only as directed. ▪ these tablets are intended for use by normally healthy persons only. ▪ persons under 18 years of age should use only as directed by a doctor.

Stop Use:

Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.

Package Label Principal Display Panel:

Principal display panel cvs health™ compare to the active ingredient in nauzene® tablets* ndc# 69842-423-42 chewable nausea relief sodium citrate dihydrate usp 230 mg for upset stomach & nausea • aspirin free • salicylate free • with electrolyte** wild cherry flavor naturally & artificially flavored 42 chewable tablets tamper evident: do not use if printed seal under cap is broken or missing important: keep this carton for future reference on full labeling distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 © 2019 cvs/pharmacy cvs.com® 1-800-shop cvs v-16415 cvs® quality money back guarantee *this product is not manufactured of distributed by alva-amco pharmacal cos., inc., the distributor of nauzene® tablets. **sodium citrate dehydrate cvs health nausea relief 42 chewable tablets

Further Questions:

Questions 1-866-467-2748


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.