NDC 50066-534 Tukol Cough And Cold Honey Flavor

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

NDC Product Code 50066-534

NDC Code: 50066-534

Proprietary Name: Tukol Cough And Cold Honey Flavor 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.

NDC Code Structure

  • 50066 - Genomma Lab Usa
    • 50066-534 - Tukol Cough And Cold Honey Flavor

NDC 50066-534-04

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

NDC Product Information

Tukol Cough And Cold Honey Flavor with NDC 50066-534 is a a human over the counter drug product labeled by Genomma Lab Usa. The generic name of Tukol Cough And Cold Honey Flavor is dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Genomma Lab Usa

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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.

Tukol Cough And Cold Honey Flavor 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 2 mg/mL
  • GUAIFENESIN 20 mg/mL
  • PHENYLEPHRINE HYDROCHLORIDE 1 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Genomma Lab Usa
Labeler Code: 50066
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: 09-20-2019 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.

Tukol Cough And Cold Honey Flavor Product Label Images

Tukol Cough And Cold Honey Flavor 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

Distributed by: Genomma Lab USA Inc., Houston, TX, 77027

Otc - Purpose

Active ingredients (in each 5 mL tsp)PurposeDextromethorphan HBr,10 mgCough SuppressantGuaifenesin, 100 mgExpectorantPhenylephrine HCl, 5 mgNasal 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

Otc - Do Not Use

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 glandcough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulantDo not exceed recommended dosage

Stop Use And Ask A Doctor If

  • You get nervous, dizzy or sleeplesssymptoms 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.

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 periodthis adult strength product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over2 teaspoons (10 mL) every 4 hourschildren under 12do not use

Other Information

  • Each teaspoon contains: sodium 3 mgstore at 20-25°C (68-77°F). Do not refrigeratedosage cup provided

Inactive Ingredients

Anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

* Please review the disclaimer below.