Maximum Strength Mucus Relief Cold,flu And Sore Throat
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin ,phenylephrine Hcl
Wal-mart Stores,inc.,
Human Otc Drug
NDC 49035-771Maximum Strength Mucus Relief Cold,flu And Sore Throat also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin ,phenylephrine Hcl is a human otc drug labeled by 'Wal-mart Stores,inc.,'. National Drug Code (NDC) number for Maximum Strength Mucus Relief Cold,flu And Sore Throat is 49035-771. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Maximum Strength Mucus Relief Cold,flu And Sore Throat drug includes Acetaminophen - 650 mg/20mL Dextromethorphan Hydrobromide - 20 mg/20mL Guaifenesin - 400 mg/20mL Phenylephrine Hydrochloride - 10 mg/20mL . The currest status of Maximum Strength Mucus Relief Cold,flu And Sore Throat drug is Active.
Drug Information:
| Drug NDC: | 49035-771 |
| 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: | Maximum Strength Mucus Relief Cold,flu And Sore Throat |
| 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 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: | Liquid |
| 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: | ACETAMINOPHEN - 650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE - 20 mg/20mL
GUAIFENESIN - 400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/20mL
|
| 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: | 06 Sep, 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: | 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
|
| 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. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
9D2RTI9KYH
495W7451VQ
04JA59TNSJ
|
| 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. |
| Pharmacologic Class EPC: | Expectorant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Respiratory Secretion Viscosity [PE]
Increased Respiratory Secretions [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Decreased Respiratory Secretion Viscosity [PE]
Expectorant [EPC]
Increased Respiratory Secretions [PE]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49035-771-09 | 266 mL in 1 BOTTLE, PLASTIC (49035-771-09) | 06 Sep, 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. |
Purpose:
Active ingredients (in each 20 ml) purposes acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 20 mg cough suppressant guaifenesin 400 mg expectorant phenylephrine hcl 10 mg nasal decongestant
Product Elements:
Maximum strength mucus relief cold,flu and sore throat acetaminophen, dextromethorphan hydrobromide, 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 potassium citrate propylene glycol propyl gallate water sodium benzoate sorbitol sucralose xanthan gum
Indications and Usage:
Uses ⢠temporarily relieves these common cold and flu symptoms: ⢠nasal congestion ⢠sinus congestion and pressure ⢠cough due to minor throat and bronchial irritation ⢠minor aches and pains ⢠sore throat ⢠headache ⢠temporarily reduces fever ⢠temporarily 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
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: ⢠more than 6 doses in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product 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. ⢠for children under 12 years of age ⢠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 pharmac
Read more...ist 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 an enlarged prostate gland ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ⢠cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if ⢠you are taking the blood thinning drug warfarin when using this product ⢠do not use more than directed 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 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.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: ⢠more than 6 doses in 24 hours, which is the maximum daily amount ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks daily while using this product 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. ⢠for children under 12 years of age ⢠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 an enlarged prostate gland ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ⢠cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if ⢠you are taking the blood thinning drug warfarin when using this product ⢠do not use more than directed 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 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.
When Using:
When using this product ⢠do not use more than directed
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) ) ⢠do not take more than 6 doses in any 24-hour period ⢠measure only with dosing cup provided ⢠do not use dosing cup with other products ⢠dose as follows or as directed by a doctor ⢠ml= milliliter ⢠adults and children 12 years of age and older: 20 ml in dosing cup provided every 4 hours ⢠children under 12 years of age: 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 persistent headache. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel equate⢠ndc 49035-771-09 compare to mucinex® fast-max® maximum strength cold, flu & sore throat active ingredients* maximum strengthâ¡ mucus relief cold, flu & sore throat acetaminophen - pain reliever/fever reducer dextromethorphan hbr - cough suppressant guaifenesin - expectorant phenylephrine hcl - nasal decongestant ⢠relieves headache & fever ⢠helps control cough ⢠relieves nasal & chest congestion ⢠thins & loosens mucus for ages 12+ 9fl oz (266ml) tamper evident: do not use if printed seal under cap is broken or missing. â¡maximum strength per 4 hour dose. satisfaction guaranteed-or weâll replace it or give you your money back for questions or comments please call 1-888-287-1915 distributed by: wal-mart stores, inc., bentonville, ar 72716 *this product is not manufactured or distributed by reckitt benckiser, the distributor of mucinex® fast-max® maximum strength cold, flu & sore throat. equate maximum strength mucus relief cold,flu& sore throat
Further Questions:
Questions or comments? 1-888-287-1915