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  5. Label Information: Cough And Congestion Dm

FDA Label for Cough And Congestion Dm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. DIRECTIONS
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough And Congestion Dm Product Label

The following document was submitted to the FDA by the labeler of this product Agile Pharmachem. 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 Ingredient



(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg


Purpose



Cough Suppressant

Expectorant


Uses



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

Directions



  • Do not take more than 12 capsules in any 24 hour period
  • This adult product is not intend for use in children under 12 years of age
                               Age              dose
    Adults and children 12 years and over2 capsules every 4 hours
    Children under 12 yearsDo not use

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 occur with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition.

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


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Other Information



  • store at 20-25 °C(68-77 °F)
  • avoid excessive heat above 40 °C (104°F)

Inactive Ingredients



FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide


Questions Or Comments



Toll free 1-855-314-1850


Package Label.Principal Display Panel



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4e88b254-figure-01 - 4e88b254 figure 01

Cough and Congestion DM,

NDC:58805-007-75  25*300 Softgel Liquid filled


* Please review the disclaimer below.