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Docusate Sodium by Rebel Distributors Corp

Medically reviewed on February 15, 2018

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-590

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.

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 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-590(NDC:57896-401)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
D&C YELLOW NO. 10 
ETHYL VANILLIN 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MANNITOL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SORBITOL 
WATER 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize14mm
FlavorImprint CodeA92
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-590-2020 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:21695-590-3030 CAPSULE (CAPSULE) in 1 BOTTLE
3NDC:21695-590-9090 CAPSULE (CAPSULE) in 1 BOTTLE
4NDC:21695-590-00100 CAPSULE (CAPSULE) 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/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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