DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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.

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DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener 

Uses

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

Other information

Inactive ingredients

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water


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

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules
NDC. No : 53345-023-02

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Shipping Label

DOCUSATE SODIUM 100MG TWO-TONE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred, whiteScoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint Code 657
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53345-023-021 in 1 BOX04/10/2015
115000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/10/2015
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(53345-023) , ANALYSIS(53345-023)

Revised: 11/2019
Document Id: a9ff7e3d-b5ff-420b-a69b-eaea297d90b0
Set id: 7cf1df18-d658-4bff-8a62-365fc5656942
Version: 4
Effective Time: 20191107
 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.