Nighttime Cold And Flu Relief

Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate

Aurohealth Llc
Human Otc Drug
NDC 58602-769

Nighttime Cold And Flu Relief also known as Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate is a human otc drug labeled by 'Aurohealth Llc'. National Drug Code (NDC) number for Nighttime Cold And Flu Relief is 58602-769. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Nighttime Cold And Flu Relief drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 15 mg/1 Doxylamine Succinate - 6.25 mg/1 . The currest status of Nighttime Cold And Flu Relief drug is Active.

Drug Information:

Drug NDC:	58602-769
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:	Nighttime Cold And Flu Relief
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:	Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aurohealth Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
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:	ACETAMINOPHEN - 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/1 DOXYLAMINE SUCCINATE - 6.25 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:	31 Dec, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 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:	part341
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:	Aurohealth LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1094549
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:	362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
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:	Antihistamine [EPC] Histamine Receptor Antagonists [MoA] Sigma-1 Agonist [EPC] Sigma-1 Receptor Agonists [MoA] Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] Uncompetitive NMDA Receptor Antagonists [MoA]
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
58602-769-15	16 CAPSULE in 1 BOTTLE (58602-769-15)	31 Dec, 2019	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.

Other medicines with the same generic name

Nighttime Cold And Flu Relief

Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate

Capsule
Aurohealth LLC
NDC: 58602-769

Purpose:

Purpose pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Nighttime cold and flu relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 gelatin, unspecified glycerin fd&c blue no. 1 polyethylene glycol, unspecified povidone, unspecified propylene glycol water shellac sorbitol titanium dioxide q07

Indications and Usage:

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Warnings:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do Not Use:

When Using:

When using this product, do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness

Dosage and Administration:

Directions take only as directed - see overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 capsules with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other daytime or nighttime products, carefully read each label to ensure correct dosing

Stop Use:

Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Package label-principal display panel - (16 capsules bottle) aurohealth ndc 58602-769-15 compare to the active ingredients in vicks Â® nyquil Â® cold & flu nighttime relief liquicaps Â®* nighttime relief cold & flu acetaminophen, dextromethorphan hbr and doxylamine succinate capsules 325 mg/15 mg/6.25 mg aches, fever & sore throat sneezing, runny nose cough 16 capsules package label-principal display panel - (16 capsules bottle)

Further Questions:

Distributed by: aurohealth llc 2572 brunswick pike lawrenceville, nj 08648

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.