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 Puracap Pharmaceutical Llc. 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 The User Has
- 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 special and white edible ink
Questions Or Comments?
1-855-215-8180
Principal Display Panel
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Adult Long-lasting Cough Relief
Dextromethorphan HBr, USP 15 mg 20 Softgels
NDC 51013-125-15
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