NDC 58407-302 Y-tuss

Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride

NDC Product Code 58407-302

NDC 58407-302-01

Package Description: 15 mL in 1 BOTTLE

NDC 58407-302-04

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Y-tuss with NDC 58407-302 is a a human over the counter drug product labeled by Magna Pharmceuticals, Inc.. The generic name of Y-tuss is brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Magna Pharmceuticals, Inc.

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 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.

Y-tuss 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.

  • BROMPHENIRAMINE MALEATE 2 mg/5mL
  • CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/5mL
  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN (UNII: FST467XS7D)

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: Magna Pharmceuticals, Inc.
Labeler Code: 58407
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: 08-20-2019 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: 12-31-2020 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.

Y-tuss Product Label Images

Y-tuss 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

Otc - Active Ingredient

Active ingredients(in each 5mL teaspoonful)Brompheniramine Maleate 2 mgChlophedianol Hydrochloride 12.5 mgPseudoephedrine Hydrochloride 30 mg

Otc - Purpose

PurposeAntihistamineCough SuppressantNasal Decongestant

Indications & Usage

  • Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • Cough due to minor throat and bronchial irritationnasal congestionreduces swelling of nasal passagesrunny nosesneezingitchy, watery eyesitching of the nose or throat

Warnings

WarningsDo not exceed recommended dosage.

Otc - Do Not Use

  • Do not use this productif 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 physician or pharmacist before taking this product.

Otc - Ask Doctor

  • Ask a physician before use if you havea cough that lasts or is chronic such as occurs with smoking, asthma or emphysemaa cough that occurs with too much phlegm (mucus)heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomaa breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist

Ask a physician or pharmacist before use if you are taking sedatives or tranquilizers.

Otc - When Using

  • When using this productexcitability may occur, especially in childrenmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Otc - Stop Use

  • Stop use and ask a physician ifnervousness, dizziness, or sleeplessness occurcough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional befor use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.In case of an accidental overdose, seek professional help or contact a Poison Control Center immediately.

Dosage & Administration

DirectionsDo not exceed recommended dosage.Adults and children 12 years of age and over:2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teapoonfuls (40 mL) in24 hours.Children 6 to under12 years of age:1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in24 hours.Children under6 years of age:Consult a physician

Storage And Handling

Other informationStore at 59° - 86°F (15° - 30°C)

Inactive Ingredient

Inactive ingredientsCitric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Otc - Questions

Questions? Comments?Call your physician for medical advice. Serious side effects associated with this product may be reported to this number. 1-888-206-5525, 8 am - 5 pm, M-F



EST

Other

Manufactured for:MAGNAPhamaceuticals, Inc.Accountability.Louisville, KY 40299magnaweb.comRev. 07/19

* Please review the disclaimer below.