Active Ingredient (In Each Softgel)
Dextromethorphan HBr, 15 mg
Goodmeds Non-drowsy Cough Relief Capsule, Liquid Filled
FDA Label NDC 82725-4010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds Non-drowsy Cough Relief (NDC 82725-4010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cenain drugs for depression, psychiatric, cr emotional conditions, or Parkinson's disease), cr 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 could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light
Inactive Ingredients
FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol sorbitan solution. titanium dioxide
Questions Or Comments?
call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
Package Labeling:
Label (Label)
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