Tussin Dm Cough And Chest Congestion
FDA Label NDC 51013-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Tussin Dm Cough And Chest Congestion (NDC 51013-166). 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 ingredients (in each softgel), purposes, uses, 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 Ingredients (In Each Softgel)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Ask A Doctor Before Use If You Have

  •  cough that occurs with too much phlegm (mucus)
  •  cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, 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 12 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

         2 softgels every 4 hours

    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)

Inactive Ingredients

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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Tussin DM Cough & Chest Congestion

NDC 51013-166-08

*Compare to the active ingredients in Robitussin® Maximum Strength Cough Plus Chest Congestion DM

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