COLACE- docusate sodium - sennosides tablet, film coated 
Avrio Health L.P.

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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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

Inactive ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

©2020

Avrio Health L.P.

305604-0A

Colace 2-In-1
10 Tablets

Colance 2 in 1 10 tablet carton
COLACE 
docusate sodium - sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorRED (burgundy) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code P;054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-110-102 in 1 CARTON02/08/1957
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:67618-110-301 in 1 CARTON02/08/1957
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:67618-110-601 in 1 CARTON02/08/1957
360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/08/1957
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation968334974MANUFACTURE(67618-110)

Revised: 12/2021
Document Id: 002b8417-b154-4158-ac8b-2773c97b34d7
Set id: 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b
Version: 4
Effective Time: 20211213
 
Avrio Health L.P.