NDC 66513-382 Tussin Cf Non Drowsy Multi Symptom

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 66513-382

NDC 66513-382-04

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

NDC Product Information

Tussin Cf Non Drowsy Multi Symptom with NDC 66513-382 is a a human over the counter drug product labeled by Broncolin S.a De C.v.. The generic name of Tussin Cf Non Drowsy Multi Symptom is dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Broncolin S.a De C.v.

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.

Tussin Cf Non Drowsy Multi Symptom 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
  • GUAIFENESIN 200 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/10mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • MENTHOL (UNII: L7T10EIP3A)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Broncolin S.a De C.v.
Labeler Code: 66513
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: 04-30-2017 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: 12-31-2021 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.

Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Tussin Cf Non Drowsy Multi Symptom 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)

Dextromethorphan HBr 20 mgGuaifenesin 200 mgPhenylephrine HCl 10 mg

Purposes

Cough suppressantExpectorantNasal decongestant

Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubestemporarily relieves these symptoms occurring with a cold:
  • Nasal congestioncough due to minor throat and bronchial irritation

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 diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandcough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as 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 stimulant.

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 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 (1800-222-122) right away.

Directions

  • Do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing device.keep dosing cup with productmL = milliliterthis adults product is not intended for use in children under 12 years of ageadult and children 12 years and over: 10 mL every 4 hourschildren under 12 years: do not use

Other Information

  • Store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Package Label

Broncolin Multi-Symptom Cold

* Please review the disclaimer below.