Tukol Max Action Severe Congestion & Cough

Tukol Max Action Severe Congestion & Cough
SPL v8
SPL
SPL Set ID 9ac3e24a-d18a-48fc-8005-55393085d57b
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-16

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring 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, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Directions
  • Do not take more than 6 doses in any 24 hour period
  • this adult stregth product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
 age dose 
 adults and children 12 years of age and older 20 mL every 4 hours 
children under 12 years of age  do not use 

Drug Facts

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Other Information
  • Each 20 mL dose contains: sodium 10 mg
  • store between15-30°C (59-86 °F)
  • do not refrigerate
Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

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

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 professional before use

Keep Out of Reach of Children

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

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
Tukol Max Action Severe Congestion & Cough 

Tukol® MAX ACTION

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

DEXTROMETHORPHAN HBr/GUAIFENESIN/PHENYLEPHRINE HCL

Relieves

  • Cough
  • Nasal Congestion
  • Chest Congestion

Ages 12+    

6 FL OZ (177 mL)

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77098

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other oral nasal decongestant or stimulant.

Do not exceed recommended dosage.


Structured Label Content

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

Cough suppressant

Expectorant

Nasal decongestant

Warnings

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Directions
  • Do not take more than 6 doses in any 24 hour period
  • this adult stregth product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = mililiter
 age dose 
 adults and children 12 years of age and older 20 mL every 4 hours 
children under 12 years of age  do not use 

Drug Facts

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Other Information (Other information)
  • Each 20 mL dose contains: sodium 10 mg
  • store between15-30°C (59-86 °F)
  • do not refrigerate
Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-877-994-3666

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

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a professional before use

Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (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
Tukol Max Action Severe Congestion & Cough  (Tukol MAX ACTION Severe Congestion & Cough )

Tukol® MAX ACTION

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

DEXTROMETHORPHAN HBr/GUAIFENESIN/PHENYLEPHRINE HCL

Relieves

  • Cough
  • Nasal Congestion
  • Chest Congestion

Ages 12+    

6 FL OZ (177 mL)

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77098

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other oral nasal decongestant or stimulant.

Do not exceed recommended dosage.


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