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  5. Label Information: Tukol Honey Children Cough And Congestion

FDA Label for Tukol Honey Children Cough And Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Tukol Honey Children Cough And Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:

* Please review the disclaimer below.