Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM AND SENNOSIDES) TABLET, COATED [AVEMA PHARMA SOLUTIONS]
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RxNorm Names

STOOL SOFTENER (docusate sodium and sennosides) tablet, coated
[Avema Pharma Solutions]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

Active ingredients (in each tablet)

Docusate Sodium 50 mg*

Sennosides 8.6 mg**

Purpose

*Stool softener

**Stimulant laxative

Uses

relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.

Warnings

Ask a doctor before use if you have

  • stomach
  • pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over a period of 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if

  • you need to use a laxative for more than 1 week
  • you have no bowel movement or have rectal bleeding. These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health care 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

  • doses may be taken as a single dose or in divided doses preferably in the evening
adults and children 12 years of age and oldertake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children 2 to 6 years of agetake up to 1 tablet daily
children under 2 years of ageask a doctor

Other information

  • each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
  • each tablet contains: calcium 20 mg/tablet
  • store at 15°-30°C (59°-86°F), protect from excessive moisture
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Peri-Colace®.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, sodium benzoate, stearic acid, and titanium dioxide. May also contain: ethanol, FD&C Blue # 2 Aluminum Lake, maltodextrin, mineral oil, Opadry ll Red, pregelatinized starch, silicon dioxide 50s.

Package/Label Principal Display Panel

Stool Softener Plus Stimulant Laxative 100 Tablets Packaging Label

NDC 63548-4000-*1

Compare to the active ingredients of Peri-Colace®*

STOOL SOFTENER PLUS STIMULANT LAXATIVE

DOCUSATE SODIUM, 50 MG

PLUS SENNOSIDES, 8.6 MG

For Relief of Occasional Constipation

100 TABLETS

STOOL SOFTENER 
docusate sodium and sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63548-4000
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-4000-1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/02/2010
Labeler - Avema Pharma Solutions (804087749)

Revised: 2/2010
 
Avema Pharma Solutions

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