Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]
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STOOL SOFTENER (docusate sodium) capsule, liquid filled
[Unit Dose Services]


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)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

ask a health professional before use. If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

Directions

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

• sodium 5 mg. very low sodium each softgel contains:

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Do not use if imprinted seal under cap is missing or broken. Tamper Evident:

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED

Label Image
STOOL SOFTENER  
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50436-1223(NDC:57896-401)
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 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
WATER 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MANNITOL 
Product Characteristics
Colorred (reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-1223-130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2000
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIBusiness Operations
Unit Dose Services831995316REPACK(50436-1223)

Revised: 4/2013
 
Unit Dose Services

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