Tukol Children Cough And Congestion Syrup
FDA Label NDC 50066-308

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 for the product Tukol Children Cough And Congestion (NDC 50066-308). 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 other, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Do not exceed recommended dosage.

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098

Otc - Purpose

 Active Ingredient (in each 5 mL or 1 teaspoon) Purpose
 Dextromethorphan HBr, 5 mg Cough Suppressant
 Guaifenesin, 50 mg Expectorant
 Phenylephrine HCl, 2.5 mg Nasal Decongestant                            

Uses

  • helps 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

Otc - Do Not Use

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.

Otc - Stop Use

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • 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 persistant headache. These could be signs of a serious condition.

Otc - 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 (1-800-222-1222) right away.

Directions

  • Do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP = teaspoon
    • agedose
    children 6 to under 12 years

    2 teaspoons (10 mL) every 4 hours

    children 4 to under 6 years

    1 teaspoon (5 mL) every 4 hours

    children under 4 years

    do not use

Other Information

  • each teaspoon (5 mL) contains: sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate.

Inactive Ingredients

citric acid, FD&C blue #1, FD&C red #40, flavor, glyverin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

Principal Display Panel - 118 Ml Bottle Carton

Tukol®

Children's

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages
4+

Relieves:

  • COUGH
  • NASAL CONGESTION
  • CHEST CONGESTION

    • 4 FL OZ (118 ml)

    Principal Display Panel (118 ml Bottle Carton)

    Principal Display Panel (118 ml Bottle Carton)

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