Otc - Active Ingredient
Dextromethorphan HBr 15mg
Goodmeds Cough Relief Dextromethorphan Hbr Capsule, Gelatin Coated
FDA Label NDC 82725-4110
13 label sections · Submitted to the FDA by Cabinet Health P.b.c. · 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 Cough Relief Dextromethorphan Hbr (NDC 82725-4110). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Cough Suppressant
Indications & Usage
Use
temporarily relieves cough due to minor throat
and bronchial irritation as may occur with a cold.
Warnings
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.
Otc - Ask Doctor
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 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.
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 or contact a Poison Control Center right away. (1-800-222-1222)
Dosage & Administration
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 Safety Information
Other information
■ store at 20–25°C (68–77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light
Inactive Ingredient
Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone K30, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution
Otc - Questions
Questions or comments?
call
1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
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