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STOOL SOFTENER DOCUSATE SODIUM 50 MG

Medically reviewed on February 5, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 50mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-111

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.

STOOL SOFTENER DOCUSATE SODIUM 50mg, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 50 mg

Purpose

Stool softener

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 lasts 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 signs of a serious condition.
  • you need to use a stool softener 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 6 softgels daily

Children 2 to under 12 years of age

take 1 to 3 softgels daily

children under 2 years

ask a doctor

Other information
  • each softgel contains: sodium 3 mg
    VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F)

    Keep tightly closed.

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China

PRINCIPAL DISPLAY PANEL - 30 SOFTGEL CAROTN

STOOL SOFTENER

NDC 51013-111-20

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant free

Gentle & effective

Comfortable relief of constipation

30 Softgels

PRINCIPAL DISPLAY PANEL - 100 SOFTGEL CAROTN

STOOL SOFTENER

NDC 51013-111-24

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant free

Gentle & effective

Comfortable relief of constipation

100 Softgels

STOOL SOFTENER DOCUSATE SODIUM 50 MG 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
D&C RED NO. 33 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
ANHYDROUS CITRIC ACID 
Product Characteristics
Colorred (clear) Scoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint CodePC20
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-111-201 BOTTLE, PLASTIC in 1 CARTON
130 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
2NDC:51013-111-241 BOTTLE, PLASTIC in 1 CARTON
2100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/22/2014
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287analysis(51013-111), manufacture(51013-111)

 
PuraCap Pharmaceutical LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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