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 over take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:67618-106
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED (burgundy) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code P054
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-106-04 1 in 1 CARTON
1 4 in 1 BLISTER PACK
2 NDC:67618-106-10 2 in 1 CARTON
2 5 in 1 BLISTER PACK
3 NDC:67618-106-30 1 in 1 CARTON
3 30 in 1 BOTTLE, PLASTIC
4 NDC:67618-106-60 1 in 1 CARTON
4 60 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 02/08/1957
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Business Operations
Purdue Pharma 250955291 PACK(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