DYRAX-Q TAB- bisacodyl, docusate sodium tablet 
Cho-A Pharm.Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dyrax-Q Tab

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

Dyrax-Q Tab

DYRAX-Q TAB 
bisacodyl, docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg  in 161 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM16.75 mg  in 161 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58354-117-021 in 1 BOX10/25/201910/26/2019
1NDC:58354-117-011 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/25/2019
Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
Establishment
NameAddressID/FEIBusiness Operations
Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-117)

Revised: 3/2023
Document Id: f6f8c887-b6f3-236a-e053-6394a90a0833
Set id: 95b98359-5002-b8f4-e053-2995a90a8961
Version: 8
Effective Time: 20230315
 
Cho-A Pharm.Co.,Ltd.