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  5. Label Information: Guaifenesin And Dextromethorphan Hydrobromide

FDA Label for Guaifenesin And Dextromethorphan Hydrobromide

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. TAMPER-EVIDENT
    11. INACTIVE INGREDIENTS
    12. OTHER INFORMATION
    13. QUESTIONS
    14. HOW SUPPLIED
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin And Dextromethorphan Hydrobromide Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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



Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg


Purpose



Cough suppressant
Expectorant


Uses



  • temporarily relieves cough due to minor throat and bronchial
    irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions
    to make coughs more productive

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



  • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If



  • cough lasts more than 7 days or occurs with fever, rash, or
    headaches that lasts. This could be a sign of a serious condition
  • hypersensitive to any ingredients

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



  • do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

    • adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
    children 6 to 12 years of age1 teaspoonful (TSP) every 4 hours
    children under 6 yearsDO NOT USE


Inactive Ingredients



Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate


Other Information



  • store at room temperature 20°-25°C (68°-77°F)
  • each 5 mL contains: sodium 3 mg

How Supplied



Dextromethorphan HBr, USP 10 mg - Guaifenesin, USP 100 mg.

  • NDC 72162-2277-2: 237 mL in a Bottle.

    • Store at room temperature 20°-25°C (68°-77°F)

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504


Package Label.Principal Display Panel



Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL

Label - lbl721622277

Label - lbl721622277


* Please review the disclaimer below.