PERI-COLACE- docusate sodium and sennosides tablet, film coated 
Purdue Products LP

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.

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Peri-Colace

Drug Facts

Active ingredients (in each tablet)

Docusate sodium           50 mg

Sennosides                        8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

WARNINGS

Do not use

Ask a doctor before use if you have

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

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

   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
Document Id: f63ecf22-fb2b-8677-5bfe-c6ac368977a3
Set id: f63ecf22-fb2b-8677-5bfe-c6ac368977a3
Version: 1
Effective Time: 20130916
 
Purdue Products LP