1. Home
  2. Labeler Index
  3. Method Pharmaceuticals
  4. 58657-505
  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. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. QUESTIONS
    13. PRINCIPAL DISPLAY PANEL

Guaifenesin And Dextromethorphan Hydrobromide Product Label

The following document was submitted to the FDA by the labeler of this product Method Pharmaceuticals. 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 under 12 yearsDO NOT USE


Inactive Ingredients



Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF


Other Information



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

Principal Display Panel



Method Pharmaceuticals

NDC 58657-505-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grap Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Fort Worth, TX 76118 Rev. 06/2016

PDP - PDP

PDP - PDP


* Please review the disclaimer below.