NDC 72828-313 Mucinar Kids Plus

Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl

NDC Product Code 72828-313

NDC Code: 72828-313

Proprietary Name: Mucinar Kids Plus Additional informationCallout TooltipWhat 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: Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl Additional informationCallout TooltipWhat 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.


Code Structure
  • 72828 - Plus Distributors Llc
    • 72828-313 - Mucinar Kids Plus

NDC 72828-313-04

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Mucinar Kids Plus with NDC 72828-313 is a a human over the counter drug product labeled by Plus Distributors Llc. The generic name of Mucinar Kids Plus is brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Plus Distributors Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Mucinar Kids Plus Active Ingredient(s)

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

  • BROMPHENIRAMINE MALEATE 2 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Plus Distributors Llc
Labeler Code: 72828
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Mucinar Kids Plus Product Label Images

Mucinar Kids Plus 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

Active Ingredients (In Each 10 Ml)

Brompheniramine maleate 2 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purposes

AntihistamineCough suppressantNasal decongestant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergiestemporarily relieves these symptoms due to hay fever (allergic rhinitis):runny nosesneezingitchy, watery eyesitching of the nose or throattemporarily restores freer breathing through the nose

Do Not Use

  • To sedate a child or to make a child sleepyif 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 disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or persistent or chronic cough that lasts such occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers

When Using This Product

  • Do not use more than directedmarked drowsiness may occuravoid alcoholic beveragesalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Nervousness, dizziness or sleeplessness occurssymptoms do not improve within 7 days or are accompanied by fevercough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than 6 doses in a 24-hour period
  • Measure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with product
  • ML = milliliter age doseadults and children 12 years and over20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 yearsdo not use

Other Information

  • Each 10 mL contains: sodium 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients

Citric acid, FD&C blue #1, FD&C red 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Package Label

Mucinar Kids PLUS

* Please review the disclaimer below.

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