Severe Cold Plus Flu Daytime Nighttime

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

Cvs Pharmacy,inc.
Human Otc Drug
NDC 69842-546

Severe Cold Plus Flu Daytime Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate is a human otc drug labeled by 'Cvs Pharmacy,inc.'. National Drug Code (NDC) number for Severe Cold Plus Flu Daytime Nighttime is 69842-546. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Severe Cold Plus Flu Daytime Nighttime drug includes . The currest status of Severe Cold Plus Flu Daytime Nighttime drug is Active.

Drug Information:

Drug NDC:	69842-546
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:	Severe Cold Plus Flu Daytime Nighttime
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, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate
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:	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:	14 Jul, 2017
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:	CVS Pharmacy,Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1534835 1550968 1804384
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
69842-546-12	1 KIT in 1 CARTON (69842-546-12) * 6 POWDER, FOR SOLUTION in 1 CARTON * 6 POWDER, FOR SOLUTION in 1 CARTON	14 Jul, 2017	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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Kit
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NDC: 37000-045

Vicks Dayquil And Vicks Nyquil Severe Cold And Flu

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NDC: 37000-814

Severe Cold Plus Flu Daytime Nighttime

Acetaminophen & more..

Kit
CVS Pharmacy,Inc.
NDC: 69842-546

Alka-seltzer Plus Day And Night Severe Cold And Flu

Acetaminophen & more..

Kit
Bayer HealthCare LLC.
NDC: 0280-0924

Purpose:

Active ingredients (in each packet) purposes acetaminophen 500 mg pain reliever/fever reducer dextromethorphan hydrobromide 20 mg cough suppressant guaifenesin 400 mg expectorant phenylephrine hydrochloride 10 mg nasal decongestant

Active ingredients (in each packet) purposes acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hydrobromide 20 mg cough suppressant doxylamine succinate 12.5 mg antihistamine phenylephrine hydrochloride 10 mg nasal decongestant

Product Elements:

Severe cold plus flu daytime nighttime acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate severe cold plus flu daytime acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid maltodextrin potassium citrate silicon dioxide sucralose sucrose fd&c yellow no. 6 severe cold plus flu nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine anhydrous citric acid maltodextrin potassium citrate silicon dioxide sucralose sucrose fd&c yellow no. 6

Indications and Usage:

Uses âª temporarily relieves these symptoms due to a cold or flu: âª minor aches and pains âª headache âª sore throat âª cough âª nasal congestion âª sinus congestion and pressure âª helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus âª temporarily reduces fever

Uses âª temporarily relieves these symptoms due to a cold or flu: âª headache âª minor aches and pains âª cough âª sore throat âª nasal congestion âª sinus congestion and pressure âª runny nose âª sneezing âª temporarily reduces fever

Warnings:

s 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. âª if you have ever had an allergic reaction to this product or any of its ingredients âª in children under 12 years of age ask a doctor before use if you have âª liver disease âª heart disease âª high blood pressure âª thyroid disease âª diabetes âª difficulty in urination due to enlargement of the prostate gland âª persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema âª cough with excessive phlegm (mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage stop use and ask a doctor if âª pain, cough, or nasal congestion gets worse or lasts more than 7 days âª fever gets worse or lasts more than 3 days âª redness or swelling is present âª new symptoms occur âª cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. âª nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

in 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. âª if you have ever had an allergic reaction to this product or any of its ingredients âª in children under 12 years of age ask a doctor before use if you have âª liver disease âª heart disease âª high blood pressure âª thyroid disease âª diabetes âª glaucoma âª cough with excessive phlegm (mucus) âª a breathing problem such as emphysema or chronic bronchitis âª difficulty in urination due to enlargement of the prostate gland âª persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are âª taking the blood thinning drug warfarin âª taking sedatives or tranquilizers when using this product âª do not exceed recommended dosage âª may cause marked drowsiness âª avoid alcoholic drinks âª alcohol, sedatives, and tranquilizers may increase drowsiness âª be careful when driving a motor vehicle or operating machinery âª excitability may occur, especially in children stop use and ask a doctor if âª pain, cough, or nasal congestion gets worse or lasts more than 7 days âª fever gets worse or lasts more than 3 days âª redness or swelling is present âª new symptoms occur âª cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. âª nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. 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 you take âª more than 6 packets in 24 hours, which is the maximum daily amount for this product âª with other drugs containing acetaminophen âª 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: âª skin reddening âª blisters 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 âª with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. âª 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. âª if you have ever had an allergic reaction to this product or any of its ingredients âª in children under 12 years of age ask a doctor before use if you have âª liver disease âª heart disease âª high blood pressure âª thyroid disease âª diabetes âª difficulty in urination due to enlargement of the prostate gland âª persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema âª cough with excessive phlegm (mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage stop use and ask a doctor if âª pain, cough, or nasal congestion gets worse or lasts more than 7 days âª fever gets worse or lasts more than 3 days âª redness or swelling is present âª new symptoms occur âª cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. âª nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. 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 âª more than 5 packets in 24 hours, which is the maximum daily amount for this product âª with other drugs containing acetaminophen âª 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: âª skin reddening âª blisters is a skin or general allergic reaction occurs, stop use and seek medical help right away 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 to sedate children. do not use âª with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. âª 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. âª if you have ever had an allergic reaction to this product or any of its ingredients âª in children under 12 years of age ask a doctor before use if you have âª liver disease âª heart disease âª high blood pressure âª thyroid disease âª diabetes âª glaucoma âª cough with excessive phlegm (mucus) âª a breathing problem such as emphysema or chronic bronchitis âª difficulty in urination due to enlargement of the prostate gland âª persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are âª taking the blood thinning drug warfarin âª taking sedatives or tranquilizers when using this product âª do not exceed recommended dosage âª may cause marked drowsiness âª avoid alcoholic drinks âª alcohol, sedatives, and tranquilizers may increase drowsiness âª be careful when driving a motor vehicle or operating machinery âª excitability may occur, especially in children stop use and ask a doctor if âª pain, cough, or nasal congestion gets worse or lasts more than 7 days âª fever gets worse or lasts more than 3 days âª redness or swelling is present âª new symptoms occur âª cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. âª nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. 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 exceed recommended dosage

When using this product âª do not exceed recommended dosage âª may cause marked drowsiness âª avoid alcoholic drinks âª alcohol, sedatives, and tranquilizers may increase drowsiness âª be careful when driving a motor vehicle or operating machinery âª excitability may occur, especially in children

Dosage and Administration:

Directions âª do not take more than the recommended dose âª take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor âª adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. consume entire drink within 10-15 minutes. âª children under 12 years: do not use

Directions âª do not take more than the recommended dose âª take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor âª adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. consume entire drink within 10-15 minutes. âª children under 12 years: do not use

Stop Use:

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

Adverse Reactions:

Allergy alert acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: âª skin reddening âª blisters

Allergy alert acetaminophen may cause severe skin reactions. symptoms may include: âª skin reddening âª blisters is a skin or general allergic reaction occurs, stop use and seek medical help right away

Package Label Principal Display Panel:

Principal display panel- c ompare to alka-seltzer plus Â® severe cold +flu day and night active ingredients* daytime severe cold & flu acetaminophen / pain reliever-fever reducer dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenylephrine hcl / nasal decongestant relieves: â¢ nasal congestion â¢ headache â¢ sore throat â¢ body ache â¢ cough â¢ mucus â¢ chest congestion â¢ fever honey lemon flavor naturally and artificially flavored nighttime severe cold & flu acetaminophen / pain reliever-fever reducer dextromethorphan hbr / cough suppressant doxylamine succinate / antihistamine phenylephrine hcl / nasal decongestant relieves: â¢ nasal congestion â¢ headache â¢ sore throat â¢ body ache â¢ cough â¢ runny nose â¢ fever honey lemon flavor naturally and artificially flavored tamper evident: do not use if individual pouch is torn or open do not take these products at the same time 6 day packets + 6 night packets 12 total distributed by: cvs pharmacy, inc. one cvs drive woonsocket, ri 02895 Â©2017 cvs/pharmacy cvs.com Â® 1-800-shop cvs money back guarantee *these products is not manufactured or distributed by bayer healthcare, llc, distributor of alka-seltzer plusÂ® severe cold +flu day and night. severe cold plus flu daytime and nighttime honey lemon flavor

Further Questions:

Questions or comments? 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.