Vicks Childrens Cough Congestion Night
Phenylephrine Hydrochloride And Diphenhydramine Hydrochloride
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 37000-712Vicks Childrens Cough Congestion Night also known as Phenylephrine Hydrochloride And Diphenhydramine Hydrochloride is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Vicks Childrens Cough Congestion Night is 37000-712. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Vicks Childrens Cough Congestion Night drug includes Diphenhydramine Hydrochloride - 12.5 mg/15mL Phenylephrine Hydrochloride - 5 mg/15mL . The currest status of Vicks Childrens Cough Congestion Night drug is Active.
Drug Information:
| Drug NDC: | 37000-712 |
| 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 Night |
| 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 Night |
| 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: | Phenylephrine Hydrochloride And Diphenhydramine 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: | Liquid |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 12.5 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/15mL
|
| 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: | 22 Apr, 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: | 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: | 2166129
|
| 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: | TC2D6JAD40
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 37000-712-06 | 177 mL in 1 BOTTLE, PLASTIC (37000-712-06) | 22 Apr, 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. |
Purpose:
Purpose antihistamine/cough suppressant nasal decongestant
Product Elements:
Vicks childrens cough congestion night phenylephrine hydrochloride and diphenhydramine hydrochloride glycerin sodium benzoate polysorbate 20 sucralose sodium citrate sodium chloride anhydrous citric acid propylene glycol water saccharin sodium diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine sorbitol clear
Indications and Usage:
Uses temporarily relieves common cold symptoms: nasal congestion runny nose & sneezing cough due to minor throat and bronchial irritation
Warnings:
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, an
Read more...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.
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
Dosage and Administration:
Directions â¢take only as directed â¢use dose cup provided â¢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.
Package Label Principal Display Panel:
Principal display panel - 177 ml bottle label vicks ® children's cough congestion night phenylephrine hci - nasal decongestant diphenhydramine hci - antihistamine/cough suppressant free of: artificial dyes & flavors, high fructose corn syrup & alcohol cough runny nose stuffy nose sneezing ages 6+ 6 fl oz (177 ml) 712
Further Questions:
Questions? 1-800-362-1683