SENNA AND DOCUSATE SODIUM - senna and docusate sodium tablet, film coated 
Sunrise Pharmaceutical Inc

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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Unknown Title

OTC - ACTIVE INGREDIENT

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE

Stool softener and Stimulant laxative

INDICATIONS AND USAGE

WARNINGS

Do not use:

OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - 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.

OTC – IF PREGNANT OR BREAST FEEDING

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

agestarting dosagemaximum dosage
adults and children 12 years  of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years  1 tablet once a day2 tablets twice a day
children 2 to under 6 years ½ tablet once a day1 tablet twice a day
children under 2 years ask a doctorask a doctor

OTHER INFORMATION

INACTIVE INGREDIENT

Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil,  polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dda29277-figure-01
SENNA AND DOCUSATE SODIUM 
senna and docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-090
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S90
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11534-090-6060 in 1 BOTTLE
2NDC:11534-090-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/26/2007
Labeler - Sunrise Pharmaceutical Inc (168522378)
Registrant - Sunrise Pharmaceutical Inc (168522378)

Revised: 8/2013
Document Id: dda29277-e3fb-4563-a038-53838c055ff4
Set id: 56c38795-7b35-43bf-900e-07df84d27c14
Version: 2
Effective Time: 20130807
 
Sunrise Pharmaceutical Inc