PEDOXAN EXTRACT- citrus unshiu peel, saposhnikovia root, acetaminophen, dextromethorphan hydrobromide granule

PEDOXAN Extract by

Drug Labeling and Warnings

PEDOXAN Extract by is a Otc medication manufactured, distributed, or labeled by I World Pharmaceutical Co., Ltd., I World Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide

PURPOSE

minor aches and pain from colds, headache fever

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

for adults take 1 pouch per intake, 3 times a day, before or between meals

WARNINGS

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Atractylodes Rhizome(KP), Aurantium lmmature Fruit(KHP), Perilla Leaf(KP), Poria(KP)

Platycodon Root(KP), Cnidium Rhizome(KP), Bupleurum Root(KP), Pueraria Root(KP)

Schizonepeta Spike(KP), Angelica Decursiva Root(KHP), Ostericum Root(KP)

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDOXAN EXTRACT 
citrus unshiu peel, saposhnikovia root, acetaminophen, dextromethorphan hydrobromide granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73442-0014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TANGERINE (UNII: KH3E3096OO) (TANGERINE - UNII:KH3E3096OO)	TANGERINE	1 g  in 3 g
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	0.06 g  in 3 g
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) (SAPOSHNIKOVIA DIVARICATA ROOT - UNII:8H84LFK2QD)	SAPOSHNIKOVIA DIVARICATA ROOT	1 g  in 3 g
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	0.00425 g  in 3 g

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73442-0014-1	3 g in 1 POUCH; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/16/2020

Labeler - I World Pharmaceutical Co., Ltd. (688222857)

Registrant - I World Pharmaceutical Co., Ltd. (688222857)

Establishment
Name	Address	ID/FEI	Business Operations
I World Pharmaceutical Co., Ltd		688222857	manufacture(73442-0014)