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  5. Label Information: Tussin Dm

FDA Label for Tussin Dm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    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. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENT
    11. OTHER INFORMATION
    12. OTC - QUESTIONS
    13. OTHER
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tussin Dm Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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.

Otc - Active Ingredient



Active Ingredient: Guaifenesin 100 mg (in each 5 mL)

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)


Otc - Purpose



Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant


Indications & Usage



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 signs of a serious condition
  • hypersensitive to any ingredients

If Pregnant Or Breast-Feeding



  • ask a health professional before use.

Otc - Keep Out Of Reach Of Children



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


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 over
2 teaspoonfuls (10 mL)
every 4 hours
Children under 12 yearsDO NOT USE


Inactive Ingredient



Inactive ingredients

citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.


Other Information



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


Otc - Questions



Questions: 888-974-5279


Manufactured by

Silarx Pharmaceutical Inc,

19 West Street , Spring Valley

NY - 10977- USA.



Other



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, OK      74146


Package Label.Principal Display Panel




Tussin-DM (OTC)

NDC 54868-1934-2

237 mL

image of package label - 1934

image of package label - 1934



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