Goodmeds Cough Relief Dextromethorphan Hbr Capsule, Gelatin Coated
FDA Label NDC 82725-4110

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 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Softgel)

Dextromethorphan HBr, 15 mg

Purpose

Cough suppressant

Uses

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

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.

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 blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone K30, propyl gallate, purified water, sorbitol sorbitan solution

Questions Or Comments?

call 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

Bottle2 (Bottle2)

Bottle2 (Bottle2)

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