Tukol max action severe congestion and cough solution

Drug facts

Active ingredients (in each20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 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
  • cough due to minor throat and bronchial irritation
  • nasal congestion

Warnings

Do not use

  • for children under 12 years of age
  • if 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
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

When using this product

do not use more than directed

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
  • Use dose cup provided
age
dose
adults and children 12 years and older
20 mL every 4 hours
children under 12 years of age
do not use

Other information

  • Each 20 mL dose contains : sodium 14 mg
  • Store at 20-25C (68-77F)
  • do not refrigerate

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue#1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or comments?

1 877 99 GENOM (43666)

Monday to Friday from 8 AM to 6 PM, Central time.


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

Ingredients and appearance - Product information

Tukol max action severe congestion and cough solution- Dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 50066-917
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 20 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 20 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 20 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Pineapple ( UNII: 2A88ZO081O)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Propyl gallate ( UNII: 8D4SNN7V92)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Trisodium citrate dihydrate ( UNII: B22547B95K)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color BLUE Flavor PINEAPPLE

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( 50066-917)

Package label-principal display panel 6 fl oz (177 ml bottle)

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HC l

Tukol ®

MAX ACTION

SevereCONGESTION & COUGH

  • Clears Nasal & Chest Congestion
  • Thins & Loosens Mucus
  • Controls Cough

Ages 12+ 6 FL OZ (177 ml)


Package label-principal display panel6 fl oz (177 ml bottle)carton

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HC l

Tukol ®

MAX ACTION

Severe
CONGESTION & COUGH


  • Clears Nasal & Chest Congestion
  • Thins & Loosens Mucus
  • Controls Cough

Ages 12+ 6 FL OZ (177 ml)