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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

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.

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

Further information

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

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