TUKOL MAX ACTION SEVERE CONGESTION AND COUGH - dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution 
Genomma Lab USA Inc

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.

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Tukol Max Action Severe Congestion and Cough

Drug Facts

Active ingredients (in each 20 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 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
  • 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 20-25°C (68-77°F)
  • 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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HCl

Tukol®

MAX ACTION
Severe CONGESTION & COUGH

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

Ages 12+     6 FL OZ (177 ml)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)Carton

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HCl

Tukol®

MAX ACTION
Severe
CONGESTION & COUGH


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

Ages 12+     6 FL OZ (177 ml)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle) Carton

TUKOL MAX ACTION SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-917
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore    
ShapeSize
FlavorBERRY, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-917-181 in 1 CARTON11/15/201706/22/2022
1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/15/201706/22/2022
Labeler - Genomma Lab USA Inc (832323534)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(50066-917)

Revised: 11/2020
Document Id: 23b03780-096d-4a0c-9653-4260dd0b1624
Set id: aaf1322a-d6b4-494c-912c-fd1fd708d614
Version: 3
Effective Time: 20201126
 
Genomma Lab USA Inc