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  5. Label Information: Long Acting Cough Softgels

FDA Label for Long Acting Cough Softgels

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PACKAGING

Long Acting Cough Softgels Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, 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.

Drug Facts




Active Ingredient (In Each Softgel)



Dextromethorphan HBr, USP 15mg


Purpose



Cough Suppressant


Use



temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.


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

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

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

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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions



  • do not take more than 8 softgels 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 older

    		take 2 softgels every 6 to 8 hours, as needed

    children under 12 years

    		do not use


Other Information



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

Inactive Ingredients



edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution


Questions Or Comments?



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