NDC 72854-242 Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu Maximum Strength

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

NDC Product Code 72854-242

NDC CODE: 72854-242

Proprietary Name: Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night 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, Guaifenesin, Phenylephrine Hydrochloride, And 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)
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
20 MM
19 MM
Imprint(s):
VVV;SCC
VVV;LOGOCRESCENTMOON
Score: 1

NDC Code Structure

  • 72854 - Rb Health (us) Llc
    • 72854-242 - Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu

NDC 72854-242-40

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

NDC Product Information

Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu Maximum Strength with NDC 72854-242 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu Maximum Strength is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and 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: 1372652, 2549034 and 2560238.

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)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • MICA (UNII: V8A1AW0880)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • 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 Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu Maximum Strength Product Label Images

Mucinex Fast-max Day Severe Congestion And Cough And Mucinex Nightshift Night 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: RB Health (US)Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each caplet) Mucinex Fast-Max Day Severe Congestion & CoughPurposesDextromethorphan HBr 10 mgCough suppressantGuaifenesin 200 mgExpectorantPhenylephrine HCl 5 mgNasal decongestantActive ingredients (in each caplet) Mucinex Nightshift Night Cold & FluPurposesAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan HBr 10 mgCough suppressantTriprolidine HCl 1.25 mgAntihistamine

Mucinex Fast-Max Day Severe Congestion & Cough

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productivetemporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe impulse to cough to help you get to sleepthe intensity of coughingnasal congestion due to a cold

  • Do not take more than directeddo 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 Cold & Flu

  • Temporarily relieves these common cold and flu symptoms:coughminor aches and painssore throatheadacherunny nosesneezingitching 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 (Nightshift Night Cold & Flu Only)

  • 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 (Nightshift Night Cold & Flu 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 (Nightshift Night Cold & Flu 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. (Nightshift Night Cold & Flu 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 (Nightshift Night Cold & Flu only)heart disease (Fast-Max Day Severe Congestion & Cough only)high blood pressure (Fast-Max Day Severe Congestion & Cough only)thyroid disease (Fast-Max Day Severe Congestion & Cough only)diabetes (Fast-Max Day Severe Congestion & Cough only)glaucoma (Nightshift Night Cold & Flu only)trouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis (Nightshift Night Cold & Flu 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 warfarin (Nightshift Night Cold & Flu only)taking sedatives or tranquilizers (Nightshift Night Cold & Flu only)

When Using This Product

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

Stop Use And Ask A Doctor If

  • Pain or cough gets worse or lasts more than 7 days (Nightshift Night Cold & Flu only)fever gets worse or lasts more than 3 days (Nightshift Night Cold & Flu only)redness or swelling is present (Nightshift Night Cold & Flu only)new symptoms occur (Nightshift Night Cold & Flu only)cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Night Cold & Flu only)nervousness, dizziness, or sleeplessness occur (Fast-Max Day Severe Congestion & Cough only)symptoms do not get better within 7 days or occur with fever (Fast-Max Day Severe Congestion & Cough only)cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max Day Severe Congestion & Cough only)

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 (Nightshift Night Cold & Flu 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.

Other Information

  • Store at 20-25°C (68-77°F)

Inactive Ingredients Mucinex Fast-Max Day 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 Nightshift Night Cold & Flu

Croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, 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.