Vicks Dayquil And Vicks Nyquil Severe Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate

The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 37000-814

Vicks Dayquil And Vicks Nyquil Severe Cold And Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Vicks Dayquil And Vicks Nyquil Severe Cold And Flu is 37000-814. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Vicks Dayquil And Vicks Nyquil Severe Cold And Flu drug includes . The currest status of Vicks Dayquil And Vicks Nyquil Severe Cold And Flu drug is Active.

Drug Information:

Drug NDC:	37000-814
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 Dayquil And Vicks Nyquil Severe Cold And Flu
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Vicks Dayquil And Vicks Nyquil
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Severe Cold and Flu
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:	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate
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:
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 Jul, 2013
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:	1369842 1431245 1544175
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
37000-814-24	1 KIT in 1 PACKAGE (37000-814-24) * 354 mL in 1 BOTTLE, PLASTIC (37000-810-12) * 354 mL in 1 BOTTLE, PLASTIC (37000-812-12)	22 Jul, 2013	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:

Active ingredients (in each 15 ml tablespoon) purpose acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine hcl 5 mg nasal decongestant

Active ingredients (in each 30 ml dose cup) purpose acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 20 mg cough suppressant doxylamine succinate 12.5 mg antihistamine phenylephrine hcl 10 mg nasal decongestant

Product Elements:

Vicks dayquil and vicks nyquil severe cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate vicks dayquil severe cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride citric acid monohydrate fd&c yellow no. 6 glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol sucralose xanthan gum acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine vicks nyquil severe cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride citric acid monohydrate fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol sucralose xanthan gum acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine

Indications and Usage:

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Warnings:

t. ask a doctor before use if you have liver disease 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 ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product, do not use more than directed. stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin 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, and tranquilizers may increase drowsiness stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do Not Use:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if adult takes more than 4 doses (30 ml each) in 24 hrs child takes more than 4 doses (15 ml each) in 24 hrs taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 liver disease 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 ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product, do not use more than directed. stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. to make a child sleep ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin 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, and tranquilizers may increase drowsiness stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

When Using:

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

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, and tranquilizers may increase drowsiness

Dosage and Administration:

Directions take only as directed - see overdose warning use dose cup or tablespoon (tbsp) do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml (2 tbsp) every 4 hrs children 6 to under 12 yrs 15 ml (1 tbsp) every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use when using other dayquil or nyquil Â® products, carefully read each label to ensure correct dosing

Directions take only as directed - see overdose warning use dose cup or tablespoon (tbsp) do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 ml (2 tbsp) every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other dayquil Â® or nyquil products, carefully read each label to ensure correct dosing

Stop Use:

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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.

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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:

Principal display panel - kit carton max strength vicks day & night pack vicks Â® dayquil Â® severe cold & flu acetaminophen, phenylephrine hcl, dextromethorphan hbr, guaifenesin non-drowsy alcohol free headache, fever, sore throat minor aches & pains nasal/sinus congestion & sinus pressure cough chest congestion dayquil severe one 12 fl oz (354 ml) bottle: nyquil Â® severe cold & flu nighttime relief acetaminophen, phenylephrine hcl, doxylamine succinate, dextromethorphan hbr berry flavor headache, fever, sore throat minor aches & pains nasal/sinus congestion & sinus pressure sneezing, runny nose cough nyquil severe one 12 fl oz (354 ml) bottle 2 bottles - 1 dayquil/1 nyquil 12 fl oz (354 ml) each; total 24 fl oz oz (708 ml) 814

Further Questions:

Questions? 1-800-251-3374

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.