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  5. Label Information: Dextromethorphan Hbr And Guaifenesin

FDA Label for Dextromethorphan Hbr And Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION
    2. INACTIVE INGREDIENTS
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. PRINCIPAL DISPLAY PANEL - 5 ML UNIT DOSE CUP LABEL
    7. PRINCIPAL DISPLAY PANEL - 10 ML UNIT DOSE CUP LABEL

Dextromethorphan Hbr And Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Kesin Pharma Corporation. 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.

Dextromethorphan Hbr And Guaifenesin Oral Solution



DM Guaifenesin
Non-Narcotic, Sugar, Dye and Alcohol Free
Expectorant/Cough Suppressant


Inactive Ingredients



Trisodium citrate Dihydrate, Citric Acid Anhydrous, USP Xanthan Gum Sodium Benzoate, NF Glycerin 99.7%, USP Propylene Glycol Sucralose Powder Sodium Saccharin, USP Sorbitol Solution 70%, Non-Crystallizable Sodium Artificial Mixed Berry Flavor Purified Water


Uses



▪ Temporarily relieves cough due to minor throat and bronchial irritations as my 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 and 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.


Principal Display Panel - 5 Ml Unit Dose Cup Label



NDC 81033-213-50

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 5mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

50 X 5 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

5 mL cup label - 5ml

5 mL cup label - 5ml


Principal Display Panel - 10 Ml Unit Dose Cup Label



NDC 81033-213-51

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/200mg per 10mL

FOR INSTITUTIONAL USE ONLY

50 X 10 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

10 mL cup label - 10ml

10 mL cup label - 10ml


* Please review the disclaimer below.