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  5. Label Information: G-zyncof

FDA Label for G-zyncof

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTHER

G-zyncof Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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.

Active Ingredients (In Each 5 Ml Tsp)



Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg


Purpose



Cough Suppressant

Expectorant


Uses



  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 If You Have



  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • When using this product do not use more than directed.

Otc - Stop Use



Stop use and ask a doctor if 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.


Keep Out Of Reach Of Children.



In case of accidental 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
  • EVERY 4 HOURS
  • Adults and Children 12 years of age and over 5 mL (1 tsp)
  • Children under 12 years of age consult physician

Other Information



  • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat or humidity.

Inactive Ingredients



Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.


Other



Made in the USA for Kramer Novis.

San Juan, PR 00917

(787) 767-2072 / www.kramernovis.com


* Please review the disclaimer below.