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Docusate Sodium by PD-Rx Pharmaceuticals, Inc.

Medically reviewed on Jun 29, 2018

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: PD-Rx Pharmaceuticals, Inc.
NDC Code: 55289-493

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.

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses
  • relieves occasional constipation (irregularity)
  • results usually occurs 1 to 3 days after the first dose

Warnings

Do not use

Do not use if you are currently taking mineral oil, unless directed bya doctor

Ask a doctor before use if you
  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use

you need to use a stool softner 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
  • do not exceed recommended dose
adults and children over 12 years and older                        
take 1-3 softgels daily
children 2 to 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information
  • Each capsule contains sodium 6mg
  • store at room temperature 15 o to 30 oC (59 o to 86 oF)
  • protect from moisture

Inactive ingredients: FD&C Red #33,Edible Ink,FD&C Red #40,FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special.

Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg dosage strength.

The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side.

Bottles of 14, 30, 60, 90 and 180 softgels.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature].

Dispense in a tight, well-closed, container as defined in the USP, with a child-resistant closure (as required).

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

100 mg each

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-493
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeSC02
Contains    
Packaging
#Item CodePackage Description
1NDC:55289-493-1414 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:55289-493-3030 CAPSULE in 1 BOTTLE, PLASTIC
3NDC:55289-493-6060 CAPSULE in 1 BOTTLE, PLASTIC
4NDC:55289-493-9090 CAPSULE in 1 BOTTLE, PLASTIC
5NDC:55289-493-93180 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/12/201801/31/2038
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIOperations
PD-Rx Pharmaceuticals, Inc.156893695repack(55289-493)

 
PD-Rx Pharmaceuticals, Inc.

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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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