NDC 72689-0013

FACOL CLASSIC ONE

Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, Dl-methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate

FACOL CLASSIC ONE is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Oasis Trading. The primary component is Acetaminophen; Guaifenesin; Pseudoephedrine Hydrochloride; Methylephedrine Hydrochloride, (+/-)-; Cloperastine Hydrochloride; Chlorpheniramine Maleate.

Product ID72689-0013_7b3a3bbb-a7c6-ce1c-e053-2991aa0acba3
NDC72689-0013
Product TypeHuman Otc Drug
Proprietary NameFACOL CLASSIC ONE
Generic NameAcetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, Dl-methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-11-22
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameOASIS TRADING
Substance NameACETAMINOPHEN; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-; CLOPERASTINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength200 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 72689-0013-1

10 CAPSULE in 1 BLISTER PACK (72689-0013-1)
Marketing Start Date2018-11-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72689-0013-1 [72689001301]

FACOL CLASSIC ONE CAPSULE
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN200 mg/1

OpenFDA Data

SPL SET ID:7b3a3bbb-a7c5-ce1c-e053-2991aa0acba3
Manufacturer
UNII

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.