Active Ingredient (In 10 Ml)
Dextromethorphan Hydrobromide 20 mg
Guaifenesin USP 200 mg
Cough Be Gone
FDA Label NDC 76206-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rfx Pharmaceutical Co., Ltd. for the product Cough Be Gone (NDC 76206-001). 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 (in 10 ml), purpose, use, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, directions, 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
■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions 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
Stop Use And Ask A Doctor If
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
Directions
■ do not take more than 6 doses in any 24-hour period
■ one dose is one bottle
■ this adult product is not intended for use in children under 12 years of age
Age Dose
Adults and Children one bottle (10 ml)
12 years and over every 4 hours
Children under 12 years do not use
Inactive Ingredients
Almond oil, Citrus peel, Ginger, Honey, Loquat leaf extract, Licorice, Menthol, Purified water
Other Information
■ Store at 20-25°C (68-77°F). Do not refrigerate
Questions Or Comments ?
■ 1-800-860-0888
Package Label
Package Label (Coughbegonepink)
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