Vicks Childrens Cough Congestion

Dextromethorphan Hydrobromide, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hydrochloride

The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 69423-997

Vicks Childrens Cough Congestion also known as Dextromethorphan Hydrobromide, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Vicks Childrens Cough Congestion is 69423-997. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Vicks Childrens Cough Congestion drug includes . The currest status of Vicks Childrens Cough Congestion drug is Active.

Drug Information:

Drug NDC:	69423-997
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:	Vicks Childrens Cough Congestion
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Vicks Childrens
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	COUGH CONGESTION
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:	Dextromethorphan Hydrobromide, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	The Procter & Gamble Manufacturing Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
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:
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:	09 Jul, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 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:	M012
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:	The Procter & Gamble Manufacturing Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2166123 2166129 2626496 2626497
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:
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
69423-997-12	1 KIT in 1 PACKAGE (69423-997-12) * 177 mL in 1 BOTTLE, PLASTIC (69423-982-06) * 177 mL in 1 BOTTLE, PLASTIC (37000-712-06)	09 Jul, 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

Vicks Childrens Cough Congestion

Dextromethorphan Hydrobromide & more..

Kit
The Procter & Gamble Manufacturing Company
NDC: 69423-997

Purpose:

Antihistamine/cough suppressant nasal decongestant

Purpose cough suppressant expectorant nasal decongestant

Product Elements:

Vicks childrens cough congestion dextromethorphan hydrobromide, diphenhydramine hcl, guaifenesin, phenylephrine hydrochloride vicks childrens cough congestion phenylephrine hcl, dextromethorphan hbr, guaifenesin dextromethorphan hydrobromide dextromethorphan glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol sucralose guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid clear vicks childrens cough congestion night phenylephrine hydrochloride and diphenhydramine hydrochloride phenylephrine hydrochloride phenylephrine polysorbate 20 water saccharin sodium sodium benzoate sodium citrate sorbitol glycerin sucralose sodium chloride propylene glycol diphenhydramine hydrochloride diphenhydramine anhydrous citric acid clear

Indications and Usage:

Uses temporarily relieves common cold symptoms: nasal congestion runny nose & sneezing cough due to minor throat and bronchial irritation

Uses temporarily relieves common cold symptoms: nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings:

d tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away.

Warnings do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema a sodium-restricted diet if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. when using this product, do not use more than directed. in case of overdose, get medical help or contact a poison control center right away.

Do Not Use:

Warnings do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema a sodium-restricted diet ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product do not use more than directed. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away.

When Using:

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

When using this product, do not use more than directed.

Dosage and Administration:

Directions take only as directed use dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml every 4 hrs children 6 to under 12 yrs 15 ml every 4 hrs children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use

Stop Use:

Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache these could be signs of a serious condition.

Overdosage:

In case of overdose, get medical help or contact a poison control center right away.

Package Label Principal Display Panel:

Principal display panel - kit carton day & night pack vicks childrens cough congestion (day) phenylephrine hcl - nasal decongestant dextromethorphan hbr - cough suppressant guaifenesin - expectorant non-drowsy free of: artificial dyes & flavors, high fructose corn syrup & alcohol cough chest congestion stuffy nose ages 4+ vicks childrens cough congestion night phenylephrine hcl - nasal decongestant diphenhydramine hcl - antihistamine/cough suppressant nighttime free of: artificial dyes & flavors, high fructose corn syrup & alcohol cough runny nose stuffy nose sneezing ages 6+ 2 bottles - 6 fl oz (177 ml) each; total 12 fl oz (354 ml) 997

Further Questions:

Questions? 1-800-362-1683

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.