Tussin Sugar Free Cough
FDA Label NDC 17856-5180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Tussin Sugar Free Cough (NDC 17856-5180). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg

Purpose

Dextromethorphan HBr...................Cough suppressant Guaifenesin, USP..............................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 make coughs more productive


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

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


When Using This Product

• do not use more than directed

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 Breast-Feeding,

ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

• do not exceed 6 doses in a 24-hour period • this adult product is not intended for use in children under 12 years of age

                                                                adults and children 12 years and over     2 teaspoonfuls (tsps) every 4 hours children under 12 years                              do not use AgeDose


Other Information

sugar-free dosage cup provided

• store at controlled room temperature

alcohol-free




Inactive Ingredients

acesulfame potassium, citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


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