DOK- dok capsule 
RedPharm Drug, Inc.

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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docusate

ACTIVE INGREDIENT (IN EACH SOFTGEL)

Docusate Sodium 100 mg

PURPOSE

Stool softener laxative

USES

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

WARNINGS

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
you need to use a laxative for more than 1 week

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.

DIRECTIONS

take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over take 1 to 3 softgels daily.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

OTHER INFORMATION

each softgel contains: sodium 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

INACTIVE INGREDIENTS

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

QUESTIONS OR COMMENTS?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

docusate

DOK 
dok capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1556(NDC:0904-6457)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51;S77;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1556-220 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
2NDC:67296-1556-660 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2018
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
RedPharm Drug, Inc.828374897repack(67296-1556) , relabel(67296-1556)

Revised: 1/2018
Document Id: 68165491-0e0d-52d9-e053-2a91aa0ae5f1
Set id: 68165491-0e0c-52d9-e053-2a91aa0ae5f1
Version: 2
Effective Time: 20180101
 
RedPharm Drug, Inc.