NDC 72854-134 Mucinex Fast-max Severe Congestion And Cough Arctic Burst Maximum Strength

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

NDC Product Code 72854-134

NDC CODE: 72854-134

Proprietary Name: Mucinex Fast-max Severe Congestion And Cough Arctic Burst 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: Dextromethorphan Hydrobromide, 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.

Product Characteristics

Color(s):
GREEN (C48329)
Flavor(s):
MENTHOL (C73403)

NDC Code Structure

  • 72854 - Rb Health (us) Llc
    • 72854-134 - Mucinex Fast-max Severe Congestion And Cough Arctic Burst

NDC 72854-134-66

Package Description: 180 mL in 1 BOTTLE

NDC Product Information

Mucinex Fast-max Severe Congestion And Cough Arctic Burst Maximum Strength with NDC 72854-134 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Fast-max Severe Congestion And Cough Arctic Burst Maximum Strength is dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1043543.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Mucinex Fast-max Severe Congestion And Cough Arctic Burst Maximum Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

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 Severe Congestion And Cough Arctic Burst Maximum Strength Product Label Images

Mucinex Fast-max Severe Congestion And Cough Arctic Burst 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 07054-0224Made in England

Otc - Purpose

Active ingredients (in each 20 mL)PurposesDextromethorphan HBr 20 mgCough suppressantGuaifenesin 400 mgExpectorantPhenylephrine HCl 10 mgNasal decongestant

Uses

  • 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 intensity of coughingnasal congestion due to a coldtemporarily helps you cough less

Do Not Use

  • 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

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Otc - When Using

When using this product do not use more than directed

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occursymptoms do not get better within 7 days or occur with fevercough 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.

Directions

  • Do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctoradults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hourschildren under 12 years of age: do not use

Other Information

  • Each 20 mL contains: sodium 9 mgstore at 20-25°C (68-77°F)dosing cup provideddo not refrigerate

Inactive Ingredients

Anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

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

* Please review the disclaimer below.