Otc - Active Ingredient
Active Ingredients (in each 20 mL)
Dextromethorphan HBr 20mg
Guaifenesin 400 mg
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.
Active Ingredients (in each 20 mL)
Dextromethorphan HBr 20mg
Guaifenesin 400 mg
Purpose
Cough Suppressant
Expectorant
Uses
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 us if you have
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.
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
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.
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