FDA Label for Dextromethorphan Hydrobromide
View Indications, Usage & Precautions
Dextromethorphan Hydrobromide Product Label
The following document was submitted to the FDA by the labeler of this product One2zee Limited Liability Company. 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.
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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
Otc - Do Not Use
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
Otc - Stop Use
Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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 orcontact 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
- adults and children 12 years and over take 2 capsules 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
polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, gelatin, glycerin, sorbitol, water
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