WHITUBEN- acetaminophen, dextromethorphan hydrobromide hydrate, guaifenesin, pseudoephedrine hydrochloride, triprolidine hydrochloride hydrate capsule

WHITUBEN by

Drug Labeling and Warnings

WHITUBEN by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 180mg
Dextromethorphan Hydrobromide Hydrate 8mg
DL-Methylephedrine Hydrochloride 12.5mg
Guaifenesin 20.84mg
Pseudoephedrine Hydrochloride 15mg
Triprolidine Hydrochloride Hydrate 0.66mg

PURPOSE

relieve your cold symptoms

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

■ adult and children 15 years of age and older: 2 capsules three times a day
■ children under 15 years of age: ask a doctor

WARNINGS

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

INACTIVE INGREDIENT

cellulose, corn starch, magnesium stearate, sodium starch glycolate

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITUBEN 
acetaminophen, dextromethorphan hydrobromide hydrate, guaifenesin, pseudoephedrine hydrochloride, triprolidine hydrochloride hydrate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0037
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	180 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	20.84 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg
METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM) (METHYLEPHEDRINE, (+/-)- - UNII:SHS9PGQ2LS)	METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-	12.5 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.66 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	8 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	TWLQQ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0037-1	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/22/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0037) , label(72689-0037)