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Docusate Sodium by AiPing Pharmaceutical, Inc.

Medically reviewed on November 7, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-015

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 (double-tone)

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Docusate Sodium 100 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 1-3 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 room temperature 15-30°C

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL-SHIPPING LABEL

Docusate Sodium Softgels, USP 100mg (Double-Tone)

Quantity : 19000 Softgels

NDC. No : 11788-015-00

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
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
Colorred (Double-Tone: white and clear red) Scoreno score
ShapeOVALSize13mm
FlavorImprint CodeAS015
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-015-001 BAG in 1 BOX
119000 CAPSULE, LIQUID FILLED in 1 BAG
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(11788-015), analysis(11788-015), label(11788-015), pack(11788-015)

 
AiPing Pharmaceutical, 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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