NON-HABIT FORMING STOOL SOFTENER- docusate sodium capsule, liquid filled 
Rebel Distributors Corp

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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Non-Habit Forming Stool Softener Laxative

Active Ingredient (in each softgel capsule)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

Warnings - Do not use

Ask a doctor before use if

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you experience rectal bleeding
  • you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

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

Other information

Each capsule contains sodium 6mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions or comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Principal Display Panel

Docusate Sodium (Stool Softener) 100mg

NON-HABIT FORMING STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-125(NDC:0536-3756)
Route of Administration ORAL DEA Schedule     
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)  
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)  
Product Characteristics
Color orange (orange) Score no score
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code P51
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42254-125-30 30 in 1 BOTTLE
2 NDC:42254-125-60 60 in 1 BOTTLE
3 NDC:42254-125-00 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/29/2012
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-125)
Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-125)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-125) , REPACK(42254-125)
Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-125) , REPACK(42254-125)
Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-125)
Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(42254-125) , REPACK(42254-125)

Revised: 1/2012
Document Id: 4a58eea7-1956-4660-9899-600fd477f422
Set id: ce9f4623-e4b6-4ed3-9fb6-231d7f85bedc
Version: 2
Effective Time: 20120117
 
Rebel Distributors Corp