FDA Label for Guiafenesin

View Indications, Usage & Precautions

Guiafenesin Product Label

The following document was submitted to the FDA by the labeler of this product Sunrise Pharmaceutical Inc. 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.


Otc - Purpose



Expectorant.


Indications And Usage



Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive.


Ask A Doctor Before Use If You Have



Cough that lasts or chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Cough accompanied by too much phlegm (mucus)


Otc - Stop Use  And Ask A Doctor If



Cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.


Otc – If Pregnant 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 right away.


Directions



Take with a glass of water

Adults and children 12 years and over1 tablet every 4 hour. Max 6 doses
Children 6 to under 12 yearsDo not use
Children under 6 yearsDo not use

Other Information



Store at 15(-30(C(59(-86(F)


Inactive Ingredient



Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid.


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