Tussin Dm
FDA Label NDC 67510-0527

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Tussin Dm (NDC 67510-0527). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor ir, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each 5mL tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 100mg

Purpose

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

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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor Ir

cough lasts 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.

Directions

  • do not take more than 6 doses in any 24-hour period

    • Age
    		Dose
    adults and children 12 years and over
    		2 tsp every 4 hours
    children 6 years to under 12 years
    		1 tsp every 4 hours
    children 2 years to under 6 years
    		1/2 tsp every 4 hours
    children under 2 years
    		ask a doctor

Other Information

  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided

Inactive Ingredients

cherry flavor, citric acid, FD and C red no. 40, glycerin, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, sorbitol solution, sodium benzoate

Package Label

Tussin DM

Image Of Carton Label (Tussindm.carton)

Image Of Carton Label (Tussindm.carton)

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