FDA Label for Cough Medicine Soothing Relief

View Indications, Usage & Precautions

Cough Medicine Soothing Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rfx Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each 10 Ml)



Dextromethorphan Hbr, USP 30 mg


Purpose



Cough suppressant


Uses



■ 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



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


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

■this adult product is not intended for use in children under 12 years of age

                Age                                                    Dose

children under 12 years                                do not use

adults and children 12 years                      one bottle (10 ml) 

               and over                                        every 6-8 hours


Other Information



■protect from light ■store at 20C-25C (68F-77F)


Inactive Ingredients



apricot kernel oil, honey, fritillaria delawayi bulb, water


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