Severe Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl
Wal-mart Stores Inc
Human Otc Drug
NDC 49035-945Severe Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Severe Cold And Flu is 49035-945. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Severe Cold And Flu drug includes . The currest status of Severe Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 49035-945 |
| 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 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, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores 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: | 15 Aug, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | Wal-Mart Stores Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1116572
1375932
1424850
|
| 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 |
|---|
| 49035-945-02 | 1 KIT in 1 PACKAGE (49035-945-02) * 177 mL in 1 BOTTLE (49035-842-45) * 177 mL in 1 BOTTLE (49035-811-45) | 15 Aug, 2018 | 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 pain reliever/fever reducer cough suppressant expectorant nasal decongestant
Purpose pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Product Elements:
Severe cold and flu acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl severe cold daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose xanthan gum mixed cold and flu nighttime acetaminophen, diphenhydramine hcl, phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose xanthan gum mixed
Indications and Usage:
Uses temporarily relieves these common cold and flu symptoms: cough sore throat headache minor aches and pains nasal congestion runny nose and sneezing (nighttime only) temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only) controls cough to help you get to sleep (nighttime only)
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: blisters rash 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 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. with any other drug containing acetamin
Read more...ophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease diabetes thyroid disease liver disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only) when using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 accidental 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. if taking nighttime and daytime products, carefully read each section to ensure correct dosing. do not take day & night at the same time.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: blisters rash 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 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. 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 have ever had an allergic reaction to this product or any of its ingredients with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease diabetes thyroid disease liver disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only) when using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 accidental 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. if taking nighttime and daytime products, carefully read each section to ensure correct dosing. do not take day & night at the same time.
When Using:
When using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only)
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 use only enclosed dosing cup designed for use with this product. do not use any other dosing device. 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 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 equate⢠compare to maximum strength mucinex® fast-max® day time severe cold and night time cold & flu active ingredients â ndc 49035-945-02 maximum strength daytime severe cold acetaminophen - pain reliever/fever reducer dextromethorphan hbr - cough suppressant guaifenesin - expectorant phenylephrine hcl - nasal decongestant multi-symptom relief ⢠relieves aches, fever & sore throat ⢠controls cough ⢠relieves nasal & chest congestion ⢠thins & loosens mucus ages 12+ maximum strength nighttime cold & flu acetaminophen - pain reliever/fever reducer diphenhydramine hcl - antihistamine/ cough suppressant phenylephrine hcl - nasal decongestant multi-symptom relief ⢠relieves aches, fever & sore throat ⢠controls cough ⢠relieves nasal congestion ⢠relieves runny nose & sneezing ages 12+ two - 6 fl oz (177 ml) bottles total - 12 fl oz (355 ml) 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 â this product is not manufactured or distributed by reckitt benckiser llc, owner of the registered trademark maximum strength mucinex® fast-max® day time severe cold and night time cold & flu. 50844 rev0218c04201145 w-2203-042011-45ss satisfaction guaranteed â or weâll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. equate 44-042011 equate 44-042011
Further Questions:
Questions or comments? 1-888-287-1915