Active Ingredient(S)
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Tussin Dm Liquid
FDA Label NDC 69168-477
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Tussin Dm (NDC 69168-477). 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(s), purpose, use(s), do not use, ask a doctor before use if you, stop use and ask a doctor if, if pregnant or breastfeeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
Expectorant
Use(S)
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
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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop Use And Ask A Doctor If
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 Breastfeeding,
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 (1-800-222-1222) right away.
Directions
• do not take more than 6 doses in any 24 hour period
• this adult strength product is not intended for use in children under 12 years of age
• measure only with dosing cup provided
• keep dosing cup with product
• TSP=teaspoon • mL=milliliter • dose as follows:
Age | Dose |
adults and children 12 years and over | 10 mL every 4 hours |
children under 12 years | do not use |
Other Information
• store at 15-30°C (59-86°F). Do not refrigerate
• alcohol-free
• see bottom panel for lot number and expiration date.
Inactive Ingredients
Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.
Questions/Comments
Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)
Principal Display Panel
Tussin Label (477 Tussin Dm 1)
Tussin Carton (477 Tussin Dm 2)
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