Cough Relief
FDA Label NDC 81179-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yet Health Group Llc for the product Cough Relief (NDC 81179-015). 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 capsule), purpose, uses, warnings, otc - 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 Capsule)

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.

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 (1-800-222-1222) right away.

Directions

  • do not take more than 8 capsules 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 older take 2 capsules every 6 to 8 hours, as needed
    children under 12 years do not use

Other Information

  • store between 20˚ and 25˚C (68˚ -77˚F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

Questions?

call 1-844-735-0202

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