NDC 72854-243 Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Triprolidine Hydrochloride

NDC Product Code 72854-243

NDC CODE: 72854-243

Proprietary Name: Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus 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, Guaifenesin, Phenylephrine Hydrochloride, Triprolidine 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.

Product Characteristics

Color(s):
RED (C48326)
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
20 MM
19 MM
Imprint(s):
VVV;MSC
VVV;LOGOCRESCENTMOONPLUS
Score: 1

NDC Code Structure

NDC 72854-243-10

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

NDC 72854-243-20

Package Description: 2 KIT in 1 CARTON > 1 KIT in 1 KIT * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK

NDC 72854-243-40

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 Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength with NDC 72854-243 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1110988, 2549037 and 2560237.

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 (UNII: 2S7830E561)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • 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 (UNII: 2S7830E561)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • MICA (UNII: V8A1AW0880)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW) (UNII: 23ZQ42JZZH)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • 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: 72854
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: 07-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus Maximum Strength Product Label Images

Mucinex Sinus-max Day Pressure, Pain And Cough And Mucinex Nightshift Night Sinus 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

Mucinex Sinus-Max Day Pressure, Pain & Coughcroscarmellose 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

Mucinex Nightshift Night Sinuscroscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

Dist. by: RB Health (US) Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each caplet) Mucinex Sinus-Max Day Pressure, Pain & CoughPurposesAcetaminophen 325 mgPain relieverDextromethorphan HBr 10 mgCough suppressantGuaifenesin 200 mgExpectorantPhenylephrine HCl 5 mgNasal decongestantActive ingredients (in each caplet) Mucinex Nightshift Night SinusPurposesAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan HBr 10 mgCough suppressantPhenylephrine HCl 5 mgNasal decongestantTriprolidine HCl 1.25 mgAntihistamine

Mucinex Sinus-Max Day Pressure, Pain & Cough

  • Temporarily relieves:nasal congestionheadacheminor aches and painscoughsinus 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

  • 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 over: take 2 caplets every 4 hourschildren under 12 years of age: do not use

Mucinex Nightshift Night Sinus

  • Temporarily relieves these common cold and flu symptoms:coughnasal congestionminor aches and painssore throatheadachesneezingsinus congestion and pressurerunny noseitching of the nose or throatitchy, watery eyes due to hay fevertemporarily reduces fevercontrols cough to help you get to sleep

  • Do not take more than directed (see Overdose warning)do not take more than 8 caplets in any 24-hour periodadults and children 12 years of age and over: take 2 caplets every 4 hourschildren under 12 years of age: do not use

Liver Warning

  • This product contains acetaminophen.Severe liver damage may occur if you take:more than 4,000 mg 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.

Sore Throat Warning (Nightshift Night Sinus 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.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 diseaseglaucoma (Nightshift Night Sinus only)trouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis(Nightshift Night Sinus 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 (Nightshift Night Sinus only)

When Using This Product

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

Other Information

  • Store at 20-25°C (68-77°F)

Questions? 1-866-Mucinex (1-866-682-4639)

You may also report side effects to this phone number.

* Please review the disclaimer below.