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  4. Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle

Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Doxylamine Succinate, Phenylephrine Hcl


Cvs Pharmacy
Human Otc Drug
NDC 69842-495
Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle is 69842-495. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle drug includes . The currest status of Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle drug is Active.

Drug Information:

Drug NDC: 69842-495
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: Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle
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 Hbr, Guaifenesin, Doxylamine Succinate, Phenylephrine Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cvs Pharmacy
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: 29 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 30 Jun, 2023
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: 21 Dec, 2025
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
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1369842
1431245
2560119
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
69842-495-161 BOX in 1 BOX (69842-495-16) / 1 BOX in 1 BOX / 1 KIT in 1 BOX * 8 VIAL in 1 BOX (69842-497-08) / 30 mL in 1 VIAL * 8 VIAL in 1 BOX (69842-499-08) / 15 mL in 1 VIAL29 Jun, 202130 Jun, 2023No
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

Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle


Acetaminophen & more..

Kit
CVS Pharmacy
NDC: 69842-495

Daytime/nitetime Severe Cold And Flu Maximum Strength


Acetaminophen & more..

Kit
Meijer Distribution Inc
NDC: 41250-840

Purpose:

Purposes pain reliever/ fever reducer cough suppressant expectorant nasal decongestant

Purposes pain reliever/ fever reducer cough suppressant antihistamine nasal decongestant

Product Elements:

Cvs daytime and nighttime severe cold and flu relief bundle acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl cvs health daytime severe cold and flu relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl sorbitol solution 70% water sodium metabisulfite maltitol glycerin dextromethorphan hydrobromide dextromethorphan polyethylene glycol 600 citric acid monohydrate trisodium citrate dihydrate acetaminophen acetaminophen guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine xanthan gum propylene glycol sodium benzoate sucralose edetate disodium cvs nighttime severe cold and flu relief acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl maltitol xanthan gum sodium metabisulfite water dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine polyethylene glycol 600 propylene glycol citric acid monohydrate trisodium citrate dihydrate sodium benzoate sorbitol solution 70% sucralose edetate disodium acetaminophen acetaminophen glycerin

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:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: ■ more than 8 vials 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 allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin 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 ■ 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 o
r 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 ask a doctor or pharmacist before use if you 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 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 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 vials 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 allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin 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 ■ 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland 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 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 you take: ■ more than 8 vials 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 allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin 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 ■ 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 ask a doctor or pharmacist before use if you 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 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 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 vials 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 allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin 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 ■ 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland 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 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 ■ do not take more than directed ■ empty each single-use vial of all liquid when dosing. ■ use the chart below to confirm the dose age (years) dose children under 4 years old do not use children 4 to under 12 years old ask a doctor adults and children 12 years and over 2 single use vials (15 ml) every 4 hours while symptoms last do not exceed 8 single use vials in 24 hours

Directions ■ do not take more than directed ■ empty each single-use vial of all liquid when dosing. ■ use the chart below to confirm the dose age (years) dose children under 4 years old do not use children 4 to under 12 years old ask a doctor adults and children 12 years and over 1 single use vial (30ml) every 4 hours while symptoms last do not exceed 4 single use vials in 24 hours

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 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.

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.

Overdosage:

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.

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

Package Label Principal Display Panel:

Package package

Further Questions:

Question or comments? 1-800-719-9260

Question or comments? 1-800-719-9260


Comments/ Reviews:

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