Your browser does not support JavaScript! PERI-COLACE (DOCUSATE SODIUM - SENNOSIDES) TABLET, FILM COATED [PURDUE PRODUCTS LP]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

PERI-COLACE (docusate sodium - sennosides) tablet, film coated
[Purdue Products LP]


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 ingredients (in each tablet)

Docusate sodium           50 mg

Sennosides                        8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

WARNINGS

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If pregnant or breast-feeding, 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

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and overtake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children 2 to under 6 years of agetake up to 1 tablet daily
children under 2ask a doctor

Other information

  • each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

   Keep tightly closed.

Inactive ingredients

dicalcium phosphate, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

©2013, Purdue Products L.P.

Mfd. for: Purdue Products L.P.
Stamford, CT 06901-3431

By: Purdue Pharma, 575 Granite Court
Pickering, ON L1W 3W8, Canada
303048-0A




Peri-Colace® Tablets
NDC: 67618-106-30

303048-0A
PERI-COLACE 
docusate sodium - sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67618-106
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
STARCH, CORN 
SODIUM BENZOATE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (burgundy) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code P054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-106-041 in 1 CARTON
14 in 1 BLISTER PACK
2NDC:67618-106-102 in 1 CARTON
25 in 1 BLISTER PACK
3NDC:67618-106-301 in 1 CARTON
330 in 1 BOTTLE, PLASTIC
4NDC:67618-106-601 in 1 CARTON
460 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/08/1957
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Purdue Pharma250955291PACK(67618-106), MANUFACTURE(67618-106)

Revised: 9/2013
 
Purdue Products LP

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services