Tukol Cough and Congestion

Manufacturer
Genomma Lab USA Inc | Aurohealth LLC
Effective date
2019-12-03
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:55:41

Label at a glance#

ProductTukol Cough and Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion  cough due to minor throat and bronchial irritation

Dosage and administration

Do not take more than 6 doses in any 24 hour period This adult strength product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 teaspoons (10 ml) every 4 hours children under 12 do not use

Storage and handling

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F). Do not refrigerate dosage cup provided

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL tsp)

Dextromethorphan HBr, 10 mg
Guaifenesin, 100 mg
Phenylephrine HCl, 5 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION


  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion 
    • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION


  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant.

Do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION


  • you get nervous, dizzy or sleepless

  • symptoms do not get better within 7 days or are accompanied by fever

  • cough 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


  • Do not take more than 6 doses in any 24 hour period

  • This adult strength product is not intended for use in children under 12 years of age


age
dose
adults and children 12 years and over
2 teaspoons (10 ml) every 4 hours
children under 12
do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg

  • store at 20-25°C (68-77°F). Do not refrigerate

  • dosage cup provided


Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD & C Red 40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1 877 99 GENOM (43666)

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXPECTORANT/COUGH SUPPRESSANT/NASAL DECONGESTANT
Guaifenesin / Dextromethorphan HBr / Phenylephrine HCI

Tukol®

COUGH & CONGESTION
 

  • Quiets Cough

  • Thins and loosens phlegm

  • Clears Nasal Congestion


Ages 12+   4 FL OZ (118 ml)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL BOTTLE)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL BOTTLE)   

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXPECTORANT/COUGH SUPPRESSANT/NASAL DECONGESTANT
Guaifenesin / Dextromethorphan HBr / Phenylephrine HCI

Tukol®

COUGH & CONGESTION
 

  • Quiets Cough

  • Thins and loosens phlegm

  • Clears Nasal Congestion


Ages 12+   4 FL OZ (118 ml)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Carton Label)   

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-91850066-918-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
17d53640-4ec4-4b7d-aa96-9138756dffb044ea11d2-7f7c-46b3-8658-e0cc73c3ba222020-11-27WarningsExact identifier
spl set id: 44ea11d2-7f7c-46b3-8658-e0cc73c3ba22

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.