FDA Label for Refenesen Chest Congestion Relief PE
View Indications, Usage & Precautions
Refenesen Chest Congestion Relief PE Product Label
The following document was submitted to the FDA by the labeler of this product Reese Pharmaceutical Co.. 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.
Otc - Active Ingredient
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Guaifenesin Expectorant
Phenylephrine HCl Nasal decongestant
Indications & Usage
temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.
helps loosen phlegm;mucus
clear nasal passageways
loosens nasal congestion
drain bronchial tubes
shrinks swollen membranes
clears stuffy nose
makes coughs more productive
Warnings
do not exceed recommended dosage
Otc - Do Not Use
Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,
certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks
after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,
ask a health professional.
Otc - Ask Doctor
ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
excessive phlegm;mucus
difficulty in urination due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
Otc - Stop Use
stop use and ask a doctor if
nervousness,dizziness or sleeplessness occurs
symptoms are accompanied by fever,rash,persistent headache or excessive phlegm;mucus.
cough and congestion do not approve within 7 days or tend to recur
these could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
in case of overdose,get medical help or contact a Poison Control Center immediately.
Dosage & Administration
directions
Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed
children 6 to under 12 years of age consult a doctor
do not exceed 6 doses in a 24 hour period or as directed by a doctor.
Inactive Ingredient
croscarmellose sodium,hypromellose,lactose,magnesium stearate,mycocrystalline cellulose,mineral oil,silicon dioxide,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin. May also contain maltodextrin,povidone.
Package Label.Principal Display Panel
* Please review the disclaimer below.