Tukol cough and congestion liquid

Active ingredients

(in each5 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 useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons 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 20-25C (68-77F). 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

Ingredients and appearance - Product information

Tukol cough and congestion liquid- Dextromethorphan hbr, guaifenesin, phenylephrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 50066-918
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Levomenthol ( UNII: BZ1R15MTK7)
Sorbitol ( UNII: 506T60A25R)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color RED (a clear red colored liquid) Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Genomma Lab USA Inc( 832323534)

Establishment

Name ID/FEI Business Operations
Genomma Lab USA Inc 832323534 MANUFACTURE( 50066-918)

Package label-principal display panel -4 fl oz(118 ml bottlelabel)

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)