FDA Label for Refenesen Chest Congestion Relief
View Indications, Usage & Precautions
Refenesen Chest Congestion Relief 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
Active ingredient - (per tablet)Guaifenesin 400mg Expectoran
Otc - Purpose
Guaifenesin ; Expectorant
Indications & Usage
helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive
Ask A Doctor Before Use If You Have
Ask doctor before use if you have
persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
cough is accompanied by excessive phlegm (mucous)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
In case of overdose,get medical help or contact a poison control
cenetr immediately.
Otc - Stop Use
Stop use and ask doctor if
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Dosage & Administration
Directions • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed • Children under 6 years of age: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Package Label.Principal Display Panel
Inactive Ingredient
collioidal silicon dioxide, magnesium stearate, microcrystalline cellulose, maltodextrin, povidone, stearic acid.
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