FDA Label for Facol Classic One

View Indications, Usage & Precautions

Facol Classic One Product Label

The following document was submitted to the FDA by the labeler of this product Oasis Trading. 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



Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate


Otc - Purpose



relieve your cold symptoms


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Indications & Usage



■ adult and children 12 years of age and older: 2 capsules every 5 hours
■ children under 12 years of age: ask a doctor


Warnings



Warnings
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
fever gets worse or lasts more than 3 days
New symptoms occur
These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away


Inactive Ingredient



camauba wax cellulose, starch


Dosage & Administration



For oral use only


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