FDA Label for Cough Relief

View Indications, Usage & Precautions

Cough Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 Ingredient (In Each Softgel)



Dextromethorphan HBr, USP 15 mg


Purpose



Cough suppressant 


Use



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


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

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 8 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • age

         dose

    adults and children 12 years and over

         take 2 softgels every 6 to 8 hours, as needed

    children under 12 years

         do not use


Other Information



  • store at room temperature 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients



FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink


Questions Or Comments?



Call toll free: 248-449-9300


Principal Display Panel



ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 63868-222-20

*Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®


* Please review the disclaimer below.