Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu
Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, And Diphenhydrmaine Hydrochloride
Rb Health (us) Llc
Human Otc Drug
NDC 63824-792Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu also known as Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, And Diphenhydrmaine Hydrochloride is a human otc drug labeled by 'Rb Health (us) Llc'. National Drug Code (NDC) number for Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu is 63824-792. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu drug includes . The currest status of Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 63824-792 |
| 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: | Mucinex Fast Max Day Time Severe Congestion And Cough And Night Time Cold And Flu |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Mucinex Fast Max |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Day Time Severe Congestion and Cough and Night Time Cold and Flu |
| 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: | Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, And Diphenhydrmaine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rb Health (us) Llc |
| 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 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 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: | RB Health (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1233575
1372652
1727571
|
| 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 |
|---|
| 63824-792-01 | 1 KIT in 1 PACKAGE, COMBINATION (63824-792-01) * 2 BLISTER PACK in 1 CARTON (63824-515-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK | 15 Dec, 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:
Active ingredients (in each caplet) purposes mucinex ® fast-max ® day time severe congestion & cough dextromethorphan hbr 10mg cough suppressant guaifenesin 200mg expectorant phenylephrine hcl 5mg nasal decongestant
Active ingredients (in each caplet) purposes mucinex fast-max night time cold & flu acetaminophen 325 mg pain reliever/ fever reducer diphenhydramine hcl 12.5 mg antihistamine/cough suppressant phenylephrine hcl 5 mg nasal decongestant
Product Elements:
Mucinex fast max day time severe congestion and cough and night time cold and flu guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide, acetaminophen, and diphenhydrmaine hydrochloride mucinex fast-max severe congestion and cough guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine dextromethorphan hydrobromide dextromethorphan starch, corn fd&c blue no. 2 aluminum oxide fd&c red no. 40 magnesium stearate maltodextrin mica microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide srs mucinex fast-max night time severe cold and flu acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine starch, corn croscarmellose sodium crospovidone fd&c blue no. 1 aluminum oxide fd&c blue no. 2 ferric oxide yellow magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a mica microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium bicarbonate stearic acid talc titanium dioxide mva
Indications and Usage:
Uses temporarily relieves (day time only): cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing nasal congestion due to a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (day time only) temporarily relieves these common cold and flu symptoms (night time only): cough minor aches and pains headache nasal congestion sore throat runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever (night time only) controls cough to help you get to sleep
Warnings:
Warnings liver warning (night time only) this product contains acetaminophen. severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product allergy alert (night time only) 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 (night time only) 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. (night time only) with any other product containing diphenhydramine, even one used on the skin (night time only) if you are now taking a
Read more...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 (night time only) heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland glaucoma (night time only) a breathing problem such as emphysema or chronic bronchitis (night time only) 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 (night time only) taking sedatives or tranquilizers (night time only) when using this product do not use more than directed excitability may occur, especially in children (night time only) marked drowsiness may occur (night time only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time only) avoid alcoholic drinks (night time only) be careful when driving a motor vehicle or operating machinery (night time only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever (day time only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (night time only) fever gets worse or lasts more than 3 days (night time only) redness or swelling is present (night time only) new symptoms occur (night time only) cough comes back, or occurs with fever, 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. overdose warning (night time only) taking more than the recommended dose (overdose) may cause liver damage. 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 (night time only) this product contains acetaminophen. severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product allergy alert (night time only) 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 (night time only) 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. (night time only) with any other product containing diphenhydramine, even one used on the skin (night time only) 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 (night time only) heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland glaucoma (night time only) a breathing problem such as emphysema or chronic bronchitis (night time only) 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 (night time only) taking sedatives or tranquilizers (night time only) when using this product do not use more than directed excitability may occur, especially in children (night time only) marked drowsiness may occur (night time only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time only) avoid alcoholic drinks (night time only) be careful when driving a motor vehicle or operating machinery (night time only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever (day time only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (night time only) fever gets worse or lasts more than 3 days (night time only) redness or swelling is present (night time only) new symptoms occur (night time only) cough comes back, or occurs with fever, 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. overdose warning (night time only) taking more than the recommended dose (overdose) may cause liver damage. 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 excitability may occur, especially in children (night time only) marked drowsiness may occur (night time only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time only) avoid alcoholic drinks (night time only) be careful when driving a motor vehicle or operating machinery (night time only)
Dosage and Administration:
Directions do not take more than directed (see overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets 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 symptoms do not get better within 7 days or occur with fever (day time only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (night time only) fever gets worse or lasts more than 3 days (night time only) redness or swelling is present (night time only) new symptoms occur (night time only) cough comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - kit carton maximum strength ndc 63824-792-01 mucinex® fast-max ® day time severe congestion & cough dextromethorphan hbr â cough suppressant guaifenesin â expectorant phenylephrine hcl â nasal decongestant â controls cough â relieves nasal & chest congestion â thins & loosens mucus 20 caplets for ages 12+ night time cold & flu acetaminophen - pain reliever/fever reducer diphenhydramine hcl - antihistamine/ cough suppressant phenylephrine hcl - nasal decongestant â relieves aches, fever & sore throat â controls cough â relieves nasal congestion â relieves runny nose & sneezing 10 caplets for ages 12+ total 30 caplets principal display panel - kit carton