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Docusate Sodium by AiPing Pharmaceutical, Inc.

Medically reviewed on September 25, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-024

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 capsule, liquid filled (single-tone)

ACTIVE INGREDIENT (IN EACH SOFTGEL)

Docusate Sodium 100mg

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 1-3 softgels daily
  • children 2 to under 12 years of age: take 1 softgel daily
  • children under 2 years: ask a doctor

OTHER INFORMATION
  • each softgel contains: sodium 6 mg;
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Keep tigtly closed.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING

INACTIVE INGREDIENTS

D&C Red #33, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

QUESTIONS OR COMMENTS?

Call 1-844-374-0016

PRINCIPAL DISPLAY PANEL

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PROPYLENE GLYCOL 
SORBITOL 
D&C RED NO. 33 
FD&C YELLOW NO. 6 
WATER 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint CodeAS024
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-024-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/31/2015
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Registrant - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIOperations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-024), analysis(11788-024), label(11788-024), pack(11788-024)

 
AiPing Pharmaceutical, Inc.

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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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