Otc - Active Ingredient
Active ingredient - (per tablet)Guaifenesin 400mg Expectoran
Refenesen Chest Congestion Relief
FDA Label NDC 10956-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co for the product Refenesen Chest Congestion Relief (NDC 10956-788). 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 otc - active ingredient, otc - purpose, indications & usage, ask a doctor before use if you have, otc - keep out of reach of children, otc - stop use, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Of Carton (Reeseg450v10001)
Inactive Ingredient
collioidal silicon dioxide, magnesium stearate, microcrystalline cellulose, maltodextrin, povidone, stearic acid.
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