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

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

Warnings

Do not use

  • if you are currently 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 using 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

Adults and children 12 years of ages and over

take 1 to 3 softgels daily

Children 2 and under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor

Other information

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules
NDC. No : 53345-023-01

IMPORTANT:

  1. Inspect immediate upon receipt.
  2. This is a bulk shipment intended for further processing only.
  3. Protect from heat, humidity, and light. Do not refrigerate.
  4. Store at 15-30°C (59-86°F)

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM 100MG TWO-TONE 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-023
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color red, white (Two-Tone) Score no score
Shape CAPSULE (OVAL) Size 13mm
Flavor Imprint Code 657
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53345-023-01 1 in 1 BOX
1 20000 in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 08/11/2014
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
Name Address ID/FEI Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-023) , ANALYSIS(53345-023)

Revised: 8/2014
Document Id: c738990b-fc78-4f71-b965-78f9cb8277d9
Set id: a923e5ca-86fd-4bf9-9931-180ddfdeae66
Version: 1
Effective Time: 20140811
 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.