Tukol Multi Symptom Cold Liquid
FDA Label NDC 50066-504

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 Multi Symptom Cold (NDC 50066-504). 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 active ingredients, purposes, keep out of reach of children, uses, warnings, ask a doctor before use ask a doctor or pharmacist before use, 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

Active Ingredients

DRUG FACTS


Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg

Purposes

Cough Suppressant
Expectorant
Nasal Decongestant

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.

Uses

  •  help 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 use

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 Ask A Doctor Or Pharmacist Before Use

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.

    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.

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 - adults and children 12 years and over    Dose - 2 teaspoons every 4 hours

    Age - children under 12    Dose - do not use

Other Information

  • each teaspoon contains: sodium 3 mg
  • store at 20‐25 ° C (68‐77 ° F). Do not refrigerate.
  • dosage cup provided

Inactive Ingredients

anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

1 877 99 GENOM (43666)

Product Label Tukol 504 Dpl

Tukol ®

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

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

Non-Drowsy
Expectorant/Cough Suppressant/Nasal Decongestant

Cough & Congestion

  • Gets rid of phlegm
  • Quiets Cough
  • Clears nasal congestion

    • Adult
    EXTRA STRENGTH
    COUGH RELIEF

    4 FL OZ (118 mL)

    LOT No.
    Exp.

    BX-006/Rev.2
    Made in USA

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


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