Active Ingredient (In Each 30 Ml/2Tbsp)
Dextromethorphan 30 mg
Soothe Comfort Ii Cough Syrup
FDA Label NDC 76206-005
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 Soothe Comfort Ii Cough Syrup (NDC 76206-005). 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 each 30 ml/2tbsp), purpose, use, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, 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
Use
■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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
■ 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 Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
■ do not take more than 4 doses in any 24-hour period
■ one dose is two tablespoons (TBSP)
■ this adult product is not intended for use in children under 12 years of age
Age Dose
adults and children 12 years 30 mL (2TBSP)
and over every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
Other Information
■ store at 20-25°C (68-77°F). Do not refrigerate
Inactive Ingredients
coltsfoot flower bud extract, grosvenor momordica fruit extract, honey, peppermint extract, schisandra chinensis fruit extract, sichuan fritillary bulb extract, water, white mulberry root bark extract
Questions Or Comments?
■ 1-800-860-0888
Package Label
Package Label (Soothecomfortiioutrbx)
* Please review the disclaimer below.
