Your browser does not support JavaScript! NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]
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NON-HABIT FORMING STOOL SOFTENER (docusate sodium) capsule, liquid filled
[Rebel Distributors Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

Docusate Sodium (Stool Softener) 100mg

NON-HABIT FORMING STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-125-3030 in 1 BOTTLE
2NDC:42254-125-6060 in 1 BOTTLE
3NDC:42254-125-00100 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/FEIBusiness Operations
PSS World Medical, Inc.791528623REPACK(42254-125)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330REPACK(42254-125)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785RELABEL(42254-125), REPACK(42254-125)
Establishment
NameAddressID/FEIBusiness Operations
SCRIPT PAK964420108RELABEL(42254-125), REPACK(42254-125)
Establishment
NameAddressID/FEIBusiness Operations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-125)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distirbutors Corp.118802834RELABEL(42254-125), REPACK(42254-125)

Revised: 1/2012
 
Rebel Distributors Corp

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