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  5. Label Information: Tukol Cough And Cold Honey Flavor

FDA Label for Tukol Cough And Cold Honey Flavor

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 YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    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 Cough And Cold Honey Flavor 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 5 mL tsp)Purpose
Dextromethorphan HBr,10 mgCough Suppressant
Guaifenesin, 100 mgExpectorant
Phenylephrine HCl, 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 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 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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant

Do not exceed recommended dosage


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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


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 right away.


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
    • agedose
    adults and children 12 years and over2 teaspoons (10 mL) every 4 hours
    children under 12do 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&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions Or Comments?



1-877-99 GENOM (43666)
Monday to Friday from 8 am to 6 pm, Central time.


Principal Display Panel - 118 Ml Bottle Carton



Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl

Tukol®

X-PECTO HONEY

COUGH & COLD

* Please review the disclaimer below.