NDC 63824-558 Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength

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

NDC Product Code 63824-558

NDC CODE: 63824-558

Proprietary Name: Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 63824 - Rb Health (us) Llc
    • 63824-558 - Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu

NDC 63824-558-30

Package Description: 1 KIT in 1 CARTON * 2 BLISTER PACK in 1 CARTON > 10 TABLET, COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON > 10 TABLET, COATED in 1 BLISTER PACK

NDC 63824-558-40

Package Description: 4 KIT in 1 CARTON > 1 KIT in 1 KIT * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK

NDC Product Information

Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength with NDC 63824-558 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength is acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is kit and is administered via form.

Labeler Name: Rb Health (us) Llc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MICA (UNII: V8A1AW0880)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • MICA (UNII: V8A1AW0880)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rb Health (us) Llc
Labeler Code: 63824
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength Product Label Images

Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England

Otc - Purpose

Active ingredients (in each caplet) Mucinex FAST-MAX DAY TIME Severe Congestion & CoughPurposesDextromethorphan HBr 10 mgCough suppressantGuaifenesin 200 mgExpectorantPhenylephrine HCl 5 mgNasal decongestant

Active ingredients (in each caplet) Mucinex FAST-MAX NIGHT TIME Cold & FluPurposesAcetaminophen 325 mgPain reliever/fever reducerDiphenhydramine HCl 12.5 mgAntihistamine/cough suppressantPhenylephrine HCl 5 mgNasal decongestant

Uses

  • Temporarily relieves (DAY TIME only)cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingnasal congestion due to a coldhelps 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):coughminor aches and painsheadachenasal congestionsore throatrunny nose and sneezingtemporarily reduces fever (NIGHT TIME only)controls cough to help you get to sleep

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 amountwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this product

Allergy Alert (Night Time Only)

  • Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 drug 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver disease (NIGHT TIME only)heart diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandglaucoma (NIGHT TIME only)breathing problems such as emphysema or chronic bronchitis (NIGHT TIME only)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin (NIGHT TIME only)taking sedatives or tranquilizers (NIGHT TIME only)

When Using This Product

  • Do not use more than directedexcitability 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)

Otc - Stop Use

  • Stop use and ask a doctor ifnervousness, dizziness, or sleeplessness occursymptoms do not get better within 7 days or occur with a 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 rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Directions

  • Do not take more than directed (see Overdose warning)do not take more than 12 caplets in any 24-hour periodadults and children 12 years of age and older: take 2 caplets every 4 hourschildren under 12 years of age: do not use

Other Information

  • Store between 20-25°C (68-77°F)

Inactive Ingredients (Mucinex Fast-Max Day Time Severe Congestion & Cough)

Croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Inactive Ingredients (Mucinex Fast-Max Night Time Cold & Flu)

Croscarmellose sodium, crospovidone, FD&C blue no. 1, FD&C blue no. 2, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

* Please review the disclaimer below.