DYRAX-Q TAB- bisacodyl, docusate sodium tablet

Dyrax-Q Tab by

Drug Labeling and Warnings

Dyrax-Q Tab by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Bisacodyl 5 mg

Docusate Sodium 16.75 mg

Purpose

Laxative

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Uses

For temporary relief of occasional constipation and irregularity

Warnings

For external use only

Ask a doctor before use if you have

stomach pain, nausea or vomiting,
a sudden change in bowel habits that lasts more than 2 weeks

If Pregnant or breast-feeding, ask a health professional before use.

Directions

adults and children 15 years and older

2 tablets at once per day (at bedtime)

children 12 – 14 years

1 1/3 tablet at once per day (at bedtime)

children 8 – 11 years

1 tablet at once per day (at bedtime)

Inactive Ingredients

Corn Starch, Colloidal Silicon Dioxide, Ethanol, Hydroxypropylcellulose, Lactose Hydrate, Magnesium Stearate, Sodium Lauryl Sulfate, OPADRY OY-C-7000A WHITE, ACRYL-EZE White, Food Yellow No.203, Food Blue No.1, Purified Water, Ursodesoxycholic Acid.

Dyrax-Q Tab

INGREDIENTS AND APPEARANCE

DYRAX-Q TAB 
bisacodyl, docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg  in 161 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	16.75 mg  in 161 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-117-02	1 in 1 BOX	10/25/2019	10/26/2019
1	NDC: 58354-117-01	1 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/25/2019

Labeler - Cho-A Pharm.Co.,Ltd. (688056831)

Registrant - Cho-A Pharm.Co.,Ltd. (688056831)

Establishment
Name	Address	ID/FEI	Business Operations
Cho-A Pharm.Co.,Ltd.		688056831	manufacture(58354-117)