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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

relieve your cold symptoms

Keep out of reach of children

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

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

camauba wax cellulose, starch

For oral use only

label

FACOL CLASSIC ONE 
acetaminophen, guaifenesin, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, cloperastine hydrochloride, chlorpheniramine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN41.6 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg
METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM) (METHYLEPHEDRINE, (+/-)- - UNII:SHS9PGQ2LS) METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-12.5 mg
CLOPERASTINE HYDROCHLORIDE (UNII: PI4N7C63ND) (CLOPERASTINE - UNII:69M5L7BXEK) CLOPERASTINE HYDROCHLORIDE8 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1.25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorbrownScoreno score
ShapeOVALSize22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0013-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/22/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0013) , label(72689-0013)

Revised: 11/2018
Document Id: 7b3a3bbb-a7c6-ce1c-e053-2991aa0acba3
Set id: 7b3a3bbb-a7c5-ce1c-e053-2991aa0acba3
Version: 1
Effective Time: 20181121
 
OASIS TRADING