Cough Relief
FDA Label NDC 36800-415

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Cough Relief (NDC 36800-415). 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, use, ask a doctor before use if you have, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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

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?

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TopCare Cough Relief 

Dextromethorphan HBr, USP 15 mg  20 SOFTGELS

NDC 36800-415-15

*Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®

* Please review the disclaimer below.