Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride And Oxymetazoline Hydrochloride

Rb Health (us) Llc
Human Otc Drug
NDC 63824-509

Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride And Oxymetazoline Hydrochloride is a human otc drug labeled by 'Rb Health (us) Llc'. National Drug Code (NDC) number for Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool is 63824-509. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool drug includes . The currest status of Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool drug is Active.

Drug Information:

Drug NDC:	63824-509
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 Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool
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 Hydrochloride And Oxymetazoline 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:	01 Aug, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Jun, 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:	1000990 1656815
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
63824-509-02	1 KIT in 1 CARTON (63824-509-02) * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BOTTLE, PUMP in 1 CARTON / 22 mL in 1 BOTTLE, PUMP	01 Aug, 2020	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.

Other medicines with the same generic name

Mucinex Sinus-max Pressure, Pain And Cough And Mucinex Sinus-max Severe Congestion Relief Clear And Cool

Acetaminophen & more..

Kit
RB Health (US) LLC
NDC: 63824-509

Purpose:

Active ingredients (in each liquid gel) purposes acetaminophen 325 mg pain reliever dextromethorphan hbr 10 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine hcl 5 mg nasal decongestant

Purpose nasal decongestant

Product Elements:

Mucinex sinus-max pressure, pain and cough and mucinex sinus-max severe congestion relief clear and cool acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride and oxymetazoline hydrochloride mucinex sinus-max pressure, pain and cough acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride fd&c yellow no. 6 gelatin, unspecified glycerin lecithin, soybean mineral oil polyethylene glycol, unspecified povidone, unspecified propylene glycol shellac sorbitol titanium dioxide water acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine pc26 mucinex sinus-max severe congestion relief clear and cool oxymetazoline hydrochloride benzalkonium chloride edetate disodium eucalyptol glycine menthol, unspecified form polyethylene glycol, unspecified polysorbate 80 propylene glycol water sodium chloride sodium hydroxide oxymetazoline hydrochloride oxymetazoline

Indications and Usage:

Uses temporarily relieves: nasal congestion headache minor aches and pains cough sinus congestion and pressure 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

Uses temporarily relieves nasal congestion due to: a cold hay fever or other upper respiratory allergies promotes nasal and sinus drainage temporarily relieves sinus congestion and pressure helps clear nasal passages; shrinks swollen membranes

Warnings:

liver disease heart disease diabetes high blood pressure thyroid disease 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 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. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland when using this product do not exceed recommended dosage do not use this product for more than 3 days. use only as directed. frequent or prolonged use may cause nasal congestion to recur or worsen. this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge the use of this container by more than one person may spread infection stop use and ask a doctor if symptoms persist if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 12 liquid gels 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 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. 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 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 diabetes high blood pressure thyroid disease 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 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. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center 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 do not use more than directed

When using this product do not exceed recommended dosage do not use this product for more than 3 days. use only as directed. frequent or prolonged use may cause nasal congestion to recur or worsen. this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge the use of this container by more than one person may spread infection

Dosage and Administration:

Directions do not take more than directed (see overdose warning ) do not take more than 12 liquid gels in any 24-hour period adults and children 12 years of age and older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Directions adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. do not exceed 2 doses in any 24-hour period. children under 6 years of age: consult a doctor. shake well before use. to open, hold by the white grips then squeeze and turn cap. before using for the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. to spray, hold bottle with thumb at the base and nozzle between first and second fingers. without tilting head, insert nozzle into nostril. fully depress pump all the way down with a firm even stroke and sniff deeply. wipe nozzle clean after use. to close, turn cap until it "clicks". do not discard cap

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 fever, rash, or headache that lasts. these could be signs of a serious condition.

Stop use and ask a doctor if symptoms persist

Package Label Principal Display Panel:

Principal display panel - kit carton value pack! 2 formats in 1 (nasal spray & liquid gels) mucinexÂ® sinus-maxÂ® severe nasal congestion relief clear & cool nasal spray oxymetazoline hcl 0.05% nasal decongestant fast acting lasts 12 hours cooling menthol flavor for ages 6+ maximum strength ndc 63824-509-02 mucinexÂ® sinus-maxÂ® pressure, pain & cough acetaminophen â pain reliever dextromethorphan hbr â cough suppressant guaifenesin â expectorant â¢ phenylephrine hcl â nasal decongestant relieves sinus pressure & congestion relieves headache controls cough thins & loosens mucus actual size for ages 12+ 3/4 fl oz (22 ml) + 16 liquid gels (liquid filled capsules) label

Further Questions:

Questions? 1-866-mucinex (1-866-682-4639) you may also report side effects to this phone number.

Questions? 1-866-mucinex (1-866-682-4639) you may also report side effects to this number.

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.