MAJOR DOK DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Clinical Solutions Wholesale

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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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

for the prevention of dry, hard stools
for relief of occasional constipation.

This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health care 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

adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
children 6- 12 years of age: take 1 softgel at bedtime

Other information

each softgel contains: sodium 6mg
store at controlled room temperature 15o - 30o C (59o- 86o F)
do not use if imprinted safety seal under cap is broken or missing.
*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800)-616-2471)

MAJOR® DOK™ 100 mg Docusate Sodium

For use as a stool softener in treating & avoiding constipation

*Compare to the active ingredient in COLACE®

Product Labeling

100mg Packet
100mg Blister
100mg 90ct Bottle
100mg 30ct Bottle

Docusate Sodium 100 mg 1000 count

MAJOR DOK DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58118-7889(NDC:0904-7889)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58118-7889-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201306/28/2017
2NDC:58118-7889-830 in 1 BLISTER PACK; Type 0: Not a Combination Product07/03/201306/28/2017
3NDC:58118-7889-01 in 1 PACKET; Type 0: Not a Combination Product07/03/201306/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/23/201006/28/2017
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIBusiness Operations
Clinical Solutions Wholesale078710347REPACK(58118-7889) , RELABEL(58118-7889)

Revised: 6/2017
 
Clinical Solutions Wholesale