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  5. Label Information: Cough Suppressant And Expectorant Dm

FDA Label for Cough Suppressant And Expectorant Dm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF THE REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Cough Suppressant And Expectorant Dm Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor Inc.. 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 as may occur with cold. It helps 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



  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop Use And Ask A Doctor If



cough lasts more than 7 days, comes back, or accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of The 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 a 24-hour period
  • Repeat dose every 4 hours while symptoms last

    •           AGE                                     DOSE

    adults and children

    12 years of age and over               10 mL    

    children 6 years to

    under 12 years of age                    5 mL

    children 2 years to

    under 6 years of age                      2.5 mL

    children under

    under 2 years of age                      ask a doctor


Other Information



  • Store at 15-30°C (59-86°F)
  • Protect from freezing
  • Alcohol free
  • Protect from light
  • Each teaspoon 5mL contains: Sodium 3 mg

Inactive Ingredients



citric acid, dextrose**, flavor, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium,
sodium benzoate

** contains one or more of these ingredients


Principal Display Panel



Compare to the Active Ingredients in Robitussin DM

Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

cough suppressant, expectorant

Non-Drowsy

Alcohol Free

Relieves- coughs, chest congestion and mucus

2 FL Oz (60 mL)


* Please review the disclaimer below.