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Tukol Cough and Congestion

Medically reviewed on November 14, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: Genomma Lab USA Inc
NDC Code: 50066-918

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

(in each 5 mL tsp)

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

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

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

Warnings

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 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

taking any other oral nasal decongestant or stimulant.

Do not exceed recommended dosage.

Stop use and ask a doctor if
  • 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,

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 right away.

Directions
  • 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
  • each 10 mL contains: sodium 6 mg

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

  • dosage cup provided


Inactive ingredients

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

Questions or comments?

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)

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)

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)



   

TUKOL COUGH AND CONGESTION 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-918
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BERRY 
FD&C RED NO. 40 
GLYCERIN 
LEVOMENTHOL 
SORBITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorRED (a clear red colored liquid) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50066-918-241 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/14/2017
Labeler - Genomma Lab USA Inc (832323534)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(50066-918)

 
Genomma Lab USA Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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