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FACOL CLASSIC ONE

Medically reviewed by Drugs.com. Last updated on Nov 21, 2018.

Dosage form: capsule
Ingredients: ACETAMINOPHEN 200mg, GUAIFENESIN 41.6mg, PSEUDOEPHEDRINE HYDROCHLORIDE 15mg, METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- 12.5mg, CLOPERASTINE HYDROCHLORIDE 8mg, CHLORPHENIRAMINE MALEATE 1.25mg
Labeler: OASIS TRADING
NDC Code: 72689-0013

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN200 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN41.6 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg
METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (METHYLEPHEDRINE, (+/-)-) METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-12.5 mg
CLOPERASTINE HYDROCHLORIDE (CLOPERASTINE) CLOPERASTINE HYDROCHLORIDE8 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1.25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
Product Characteristics
ColorbrownScoreno score
ShapeOVALSize22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:72689-0013-110 CAPSULE in 1 BLISTER PACK
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/FEIOperations
OASIS TRADING689991468manufacture(72689-0013), label(72689-0013)

 
OASIS TRADING