NDC 63824-204 Mucinex Sinus-max Day Night

Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 63824-204

NDC CODE: 63824-204

Proprietary Name: Mucinex Sinus-max Day Night 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, Diphenhydramine Hydrochloride, Guaifenesin, 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

NDC 63824-204-10

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

NDC 63824-204-20

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

NDC 63824-204-40

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 Sinus-max Day Night with NDC 63824-204 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Sinus-max Day Night is acetaminophen, diphenhydramine hydrochloride, guaifenesin, 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)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • 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)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • 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, UNSPECIFIED (UNII: FZ989GH94E)
  • 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: 08-25-2015 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]
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 Sinus-max Day Night Product Label Images

Mucinex Sinus-max Day Night 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 07054-0224Made in England

Otc - Purpose

Active ingredients (in each caplet) Mucinex SINUS-MAX DAYPurposesAcetaminophen 325 mgPain relieverGuaifenesin 200 mgExpectorantPhenylephrine HCl 5 mgNasal decongestant

Active ingredients (in each caplet) Mucinex SINUS-MAX NIGHTPurposesAcetaminophen 325 mgPain relieverDiphenhydramine HCl 12.5 mgAntihistamine/cough suppressantPhenylephrine HCl 5 mgNasal decongestant

Mucinex Sinus-Max Day

  • Temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressuretemporarily promotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Mucinex Sinus-Max Night

  • Temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressurerunny nosesneezingcoughtemporarily promotes nasal and/or sinus drainage

Liver Warning

  • 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

  • Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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.with any other product containing diphenhydramine, even one used on the skin (NIGHT 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 diseaseheart diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandglaucoma (NIGHT only)a breathing problem such as emphysema or chronic bronchitis (NIGHT only)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers (NIGHT only)

When Using This Product

  • Do not use more than directedexcitability may occur, especially in children (NIGHT only)marked drowsiness may occur (NIGHT only)alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)avoid alcoholic drinks (NIGHT only)be careful when driving a motor vehicle or operating machinery (NIGHT only)

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back, or occurs with fever, 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.

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.

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 Sinus-Max Day Only)

Croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive Ingredients (Mucinex Sinus-Max Night Only)

Croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, 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.