Severe Congestion And Cough, Cold And Flu Daytime, Nighttime
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl
Walmart Inc.
Human Otc Drug
NDC 79903-146Severe Congestion And Cough, Cold And Flu Daytime, Nighttime also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl is a human otc drug labeled by 'Walmart Inc.'. National Drug Code (NDC) number for Severe Congestion And Cough, Cold And Flu Daytime, Nighttime is 79903-146. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Severe Congestion And Cough, Cold And Flu Daytime, Nighttime drug includes . The currest status of Severe Congestion And Cough, Cold And Flu Daytime, Nighttime drug is Active.
Drug Information:
| Drug NDC: | 79903-146 |
| 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 Congestion And Cough, Cold And Flu Daytime, Nighttime |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Severe Congestion And Cough, Cold And Flu |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Daytime, Nighttime |
| 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 Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walmart 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: | 22 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | WALMART INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043543
2173667
2390630
|
| 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 |
|---|
| 79903-146-45 | 1 KIT in 1 PACKAGE (79903-146-45) * 177 mL in 1 BOTTLE, PLASTIC (79903-119-54) * 177 mL in 1 BOTTLE, PLASTIC (79903-145-45) | 22 Dec, 2022 | 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 cough suppressant expectorant nasal decongestant
Purpose pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Severe congestion and cough, cold and flu daytime, nighttime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl severe congestion and cough daytime dextromethorphan hbr, guaifenesin, phenylephrine hcl dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose xanthan gum mixed cold and flu nighttime acetaminophen, dextromethorphan hbr, triprolidine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan triprolidine hydrochloride triprolidine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 glycerin propylene glycol water sodium benzoate sucralose xanthan gum mixed
Indications and Usage:
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold
Uses temporarily relieves these common cold and flu symptoms: cough headache runny nose sneezing sore throat itchy, watery eyes due to hay fever itching of the nose or throat minor aches and pains temporarily reduces fever controls cough to help you get to sleep
Warnings:
Warnings do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs 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 diabetes high blood pressure difficulty in urination due to enlargement of the prostate gland thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. these could be signs of a serious condi
Read more...tion. 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.
Warnings 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: rash blisters skin reddening 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 parkinsonâs disease), or for 2 weeks after stopping the m
Read more...aoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts 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 exceed recommended dosage excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if 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, 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. prompt 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 do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs 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 diabetes high blood pressure difficulty in urination due to enlargement of the prostate gland thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 7 days, tends to recur, or is accompanied by 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. in case of overdose, get medical help or contact a poison control center right away.
Warnings 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: rash blisters skin reddening 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 parkinsonâs 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts 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 exceed recommended dosage excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if 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, 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. prompt 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 do not exceed recommended dosage excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not take more than directed do not take more than 6 doses in any 24-hour period ml = milliliter; fl oz = fluid ounce only use the dose cup provided adults and children 12 years and over: 20 ml in dosing cup provided every 4 hours children under 12 years: do not use
Directions do not take more than directed do not take more than 4 doses in any 24-hour period ml = milliliter; fl oz = fluid ounce only use the dose cup provided adults and children 12 years and over: 20 ml in dosing cup provided every 4 hours children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. these could be signs of a serious condition.
Stop use and ask a doctor if 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 day & night cough & cold relief equate⢠ndc 79903-146-45 compare to mucinex® fast-max® severe congestion &cough and nightshift® cold & flu active ingredients* daytime severe congestion &cough dextromethorphan hbr â cough suppressant guaifenesin â expectorant phenylephrine hcl â nasal decongestant maximum strength multi-symptom relief â¢controls cough â¢relieves nasal & chest congestion â¢thins & loosens mucus for ages 12+ 2-6 fl oz (177 ml) bottles nighttime cold & flu acetaminophen âpainreliever/feverreducer dextromethorphan hbr â cough suppressant triprolidine hcl â antihistamine relieves: â¢cough, fever â¢sore throat â¢runny nose, sneezing for ages 12+ total â 12 fl oz (355 ml) do not take the daytime and nighttime products at the same time. tamper evident: do not use if imprinted safety seal under cap is broken or missing parents: learn about teen medicine abuse www.stopmedicineabuse.org distributed by: walmart inc., bentonville, ar 72716 *this product is not manufactured or distributed by rb health (us) llc, owner of the registered trademark mucinex® fast-max® severe congestion & cough and nightshift® cold & flu. 50844 org0121004/022206345 w-2203-004063-45tw satisfaction guaranteed - for questions or comments please call 1-888-287-1915. equate 44-004063 equate 44-004063
Further Questions:
Questions or comments? 1-888-287-1915