DOCUSATE SODIUM- docusate sodium capsule 
Rebel Distributors Corp

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 Sodium Drug Facts

Active ingredient

Docusate Sodium 100mg

Purpose

Stool Softener

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center right way.

Uses

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.

Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.

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

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Directions

Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.

Children under 12: consult a doctor.

Do not exceed recommended dose.

Other Information

Each softgel contains sodium 5mg.

Product from Canada or USA

Store at room temperature, 15°C-30°C (59°F-86°F)

Inactive ingredients

may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.

Distributed by:

Geri-Care Pharmaceuticals Corp.

Brooklyn, NY 11204

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Docusate Sodium 100mg

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-590(NDC:57896-401)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize14mm
FlavorImprint Code A92
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-590-2020 in 1 BOTTLE
2NDC:21695-590-3030 in 1 BOTTLE
3NDC:21695-590-9090 in 1 BOTTLE
4NDC:21695-590-00100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2007
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: 7e23b026-fee4-436a-b378-33d31d6d8b40
Set id: 7e23b026-fee4-436a-b378-33d31d6d8b40
Version: 1
Effective Time: 20110215
 
Rebel Distributors Corp