Daytime Nighttime Cold And Flu

Acetaminophen Dextromethorphan Hbr Phenylephrine Hci Doxylaminesucinate


The Kroger Co.
Human Otc Drug
NDC 30142-667
Daytime Nighttime Cold And Flu also known as Acetaminophen Dextromethorphan Hbr Phenylephrine Hci Doxylaminesucinate is a human otc drug labeled by 'The Kroger Co.'. National Drug Code (NDC) number for Daytime Nighttime Cold And Flu is 30142-667. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold And Flu drug includes . The currest status of Daytime Nighttime Cold And Flu drug is Active.

Drug Information:

Drug NDC: 30142-667
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: Daytime Nighttime Cold And Flu
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 Phenylephrine Hci Doxylaminesucinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: The Kroger Co.
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: 30 Oct, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Dec, 2025
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 Kroger Co.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1043400
1113705
1484901
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.
UPC:0041260010811
UPC stands for Universal Product Code.
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
30142-667-241 KIT in 1 KIT (30142-667-24) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE30 Oct, 2020N/ANo
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:

Purposes for day time pain reliever/fever reducer cough suppressant nasal decongestant

Purpose for night time pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Daytime nighttime cold and flu acetaminophen dextromethorphan hbr phenylephrine hci doxylaminesucinate daytime cold and flu acetaminophen dextromethorphan hbr phenylephrine hci acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c yellow no. 6 propylene glycol water trisodium citrate dihydrate glycerin saccharin sodium sodium benzoate sodium chloride sorbitol sucralose xanthan gum nighttime cold and flu acetaminophen dextromethorphan hbr doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine acesulfame potassium anhydrous citric acid alcohol d&c yellow no. 10 fd&c green no. 3 high fructose corn syrup propylene glycol water polyethylene glycol, unspecified trisodium citrate dihydrate saccharin sodium fd&c yellow no. 6

Indications and Usage:

Uses daytime temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation nighttime temporarily relieves these common cold/flu symptoms` minor aches and pains headache sore throat runny nose and sneezing fever cough due to minor throat and bronchial irritation

Warnings:

Warnings daytime liver warning: this product contains acetaminophen. severe liver damage may occur if: adult takes more than 4 doses (30 ml each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 ml each) in 24 hours taken with other drugs containing acetaminophen adult has 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. nighttime liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this pro
duct 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 daytime nighttime 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 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 child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease 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 ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not exceed recommended dosage. nighttime 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 daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime pain 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, daytime nighttime ask a health professional before use. keep out of reach of children. daytime nighttime taking more than the recommended dose (overdose) may couse liver damage. in case of overdose, get medical help or contact a poison control center(1-800-222-1222) 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 daytime liver warning: this product contains acetaminophen. severe liver damage may occur if: adult takes more than 4 doses (30 ml each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 ml each) in 24 hours taken with other drugs containing acetaminophen adult has 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. nighttime liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 daytime nighttime 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 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 child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease 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 ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not exceed recommended dosage. nighttime 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 daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime pain 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, daytime nighttime ask a health professional before use. keep out of reach of children. daytime nighttime taking more than the recommended dose (overdose) may couse liver damage. in case of overdose, get medical help or contact a poison control center(1-800-222-1222) 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 daytime do not exceed recommended dosage. nighttime 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 daytime do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product ml= milliliter adults and children 12 years and over 30 ml every 4 hours children 6 to under 12 years 15 ml every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use nighttime do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hours period measure only with dosing cup provided. do not use any other dosing device. ml= milliliter keep dosing cup with product adults and children 12 years and over: 30 ml every 6 hours children under 12 years of age: do not use

Stop Use:

Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime pain 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 compare to the active ingredient of vicks® dayquil®& vicks® nyquil® cold & flu *see side panel cold & flu daytime multi-symptom relief acetaminophen dextromethorphan hbr phenylephrine hci pain reliever fever reducer cough suppressant nasal decongestant for ages 6 years & older antihistamine free alcohol free cold & flu nighttime multi-symptom relief acetaminophen dextromethorphan hbr doxylamine succinate pain reliever fever reducer cough suppressant antihistamine for ages 12 years & older alcohol 10% fl oz (ml) when using other daytime or nighttime products, carefully read each label to ensure correct dosing *vicks®, dayquil® and nyquil® are registered trademarks of the procter & gamble company, cincinnati, oh 45202. the procter & gamble company is not affiliated with the kroger co. or these product tamper evident: do not use if printed safety seal around dosage cup or under cap is broken or missing. dist. bt the kroger co. cincinnati, ohio 45202 www.kroger.com

Product label kroger daytime nighttime cold & flu relief acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hcl 5 mg, acetaminophen 650 mg, dextromethorphan hbr 30 mg, doxylamine succinate 12.5 mg

Further Questions:

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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.