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Non-Habit Forming Stool Softener

Medically reviewed on Jan 17, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Rebel Distributors Corp
NDC Code: 42254-125

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.

Non-Habit Forming Stool Softener Laxative

Active Ingredient (in each softgel capsule)

Docusate Sodium 100mg

Purpose

Stool softener

Uses
  • Relieves occasional constipation.
  • Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use
  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present

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
  • adults and children over 12 years and over:1 capsule once daily or in divided doses
  • children 6 to under 12 years: 1 capsule once daily
  • children under 6 years: ask a doctor

Other information
  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

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

NON-HABIT FORMING STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-125(NDC:0536-3756)
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 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colororange (orange) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint CodeP51
Contains    
Packaging
#Item CodePackage Description
1NDC:42254-125-3030 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:42254-125-6060 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:42254-125-00100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/29/2012
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
NameAddressID/FEIOperations
PSS World Medical, Inc.791528623REPACK(42254-125)
Establishment
NameAddressID/FEIOperations
STAT RX USA LLC786036330REPACK(42254-125)
Establishment
NameAddressID/FEIOperations
Dispensing Solutions, Inc.066070785RELABEL(42254-125), REPACK(42254-125)
Establishment
NameAddressID/FEIOperations
SCRIPT PAK964420108RELABEL(42254-125), REPACK(42254-125)
Establishment
NameAddressID/FEIOperations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-125)
Establishment
NameAddressID/FEIOperations
Rebel Distirbutors Corp.118802834RELABEL(42254-125), REPACK(42254-125)

 
Rebel Distributors Corp

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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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