Tukol Honey Children Cough And Congestion Syrup
FDA Label NDC 50066-301

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 Honey Children Cough And Congestion (NDC 50066-301). 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, ask a doctor before use if the child has, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active ingredients (in each 2.5 mL)Purpose
Dextromethorphan HBr, 5 mgCough suppressant
Guaifenesin, 50 mgExpectorant
Phenylephrine HCl, 2.5 mgNasal 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.

Ask A Doctor Before Use If The Child Has

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • 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.

When Using This Product

  • do not use more than directed

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 persistent 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) immediately.

Directions

  • do not exceed 6 doses in a 24-hour period
  • use enclosed dosage cup
    • agedose
    children 6 to under 12 years5 mL every 4 hours
    children 4 to under 6 years2.5 mL every 4 hours
    children under 4 yearsdo not use

Other Information

  • each 5 mL contains: sodium 3 mg
  • store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

Principal Display Panel - 118 Ml Bottle Carton

NEW

Tukol®

HONEY CHILDREN

COUGH & CONGESTION

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Ages
4+

NATURAL

HONEY
FLAVOR

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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