FACOL CLASSIC ONE- acetaminophen, guaifenesin, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, cloperastine hydrochloride, chlorpheniramine maleate capsule

FACOL CLASSIC ONE by

Drug Labeling and Warnings

FACOL CLASSIC ONE by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

relieve your cold symptoms

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FACOL CLASSIC ONE 
acetaminophen, guaifenesin, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, cloperastine hydrochloride, chlorpheniramine maleate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	41.6 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg
METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM) (METHYLEPHEDRINE, (+/-)- - UNII:SHS9PGQ2LS)	METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-	12.5 mg
CLOPERASTINE HYDROCHLORIDE (UNII: PI4N7C63ND) (CLOPERASTINE - UNII:69M5L7BXEK)	CLOPERASTINE HYDROCHLORIDE	8 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1.25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0013-1	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/22/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0013) , label(72689-0013)