Tussin Dmmax Liquid
FDA Label NDC 69618-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Tussin Dmmax (NDC 69618-072). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients (in each 20 mL)

Dextromethorphan HBr 20mg

Guaifenesin 400 mg

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Indications & Usage

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

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.

Otc - Ask Doctor

Ask a doctor before us 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

Otc - Stop Use

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.

When using this prodcut, do not use more than directed.

Otc - Pregnancy Or Breast Feeding

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 right away.

Dosage & Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = mililiters
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Inactive Ingredient

Inactive ingredients 

Artificial and natural flavor, citric acid, FD&C Blue #1, FD&C Red #40, hydroxyethylcellulose, L-menthol, methylparaben, propylen glycol, propylparaben, purified water, sodium citrate, sucralose, and sucrose. 

Otc - Questions

Questions or comments?

Call 1-516-341-0666 8:30 am - 4:30 pm EST Mon-Fri

Package Label.Principal Display Panel

Image Description (Tussindmmax)

Image Description (Tussindmmax)

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