Tukol Max Action Severe Congestion And Cough Liquid
FDA Label NDC 50066-517

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc for the product Tukol Max Action Severe Congestion And Cough (NDC 50066-517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredients(in each 20 ml), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive 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 occuring 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, 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.

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

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 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 hours
  • 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 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?

1-877-99-Genom (43666)
Monday to Friday from 8 AM to 6 PM, Central time

Tukol Max Action Severe Congestion & Cough Product Label

Tukol® MAX ACTION

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

NEW 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)

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77027
    Box number: BX-064

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