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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Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative

OTC - ACTIVE INGREDIENT

Docusate sodium 50 mg, Sennoside 8.6 mg.

OTC - PURPOSE

Stimulant laxative.

INDICATIONS AND USAGE

For temporary relief of occasional constipation and irregularity.

This product 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

OTC - ASK DOCTOR

Before use if you have:

Stomach pain, nausea or vomiting

Noticed a sudden change in bowel habits that lasts over 2 weeks.

OTC - STOP USE

If you have rectal bleeding or fail to have bowel movement after use of a laxative. This could be a serious condition.

OTC - PREGNANCY 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

Drink with a full glass of water with each dose

Adults and children 12 years and overtake 2 - 4 tablets daily
Children 6 to under 12 yearstake 1 - 2 tablets daily
Children 2 to under 6 yearstake up to 1 tablet daily
Children under 2 years of ageAsk a doctor

OTHER INFORMATION

Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.

Do not use if the imprinted safety seal under cap is missing or damaged.

Store at at 25°C (77°F); excursions permitted between 15(-30(C (59(-86(F)

Keep tightly closed.

INACTIVE INGREDIENT

Colloidal silicon dioxide, dicalcium phosphate, ethanol, FD&C blue #2, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

d08a4708-figure-01
SENNA AND DOCUSATE SODIUM 
senna and docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-134
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)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S134
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11534-134-6060 in 1 BOTTLE
2NDC:11534-134-0557603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/26/2007
Labeler - Sunrise Pharmaceutical Inc (168522378)

Revised: 8/2013
Document Id: d08a4708-1de9-4bf4-8444-80d8942995b8
Set id: 68d0fe5d-5de2-4853-bf8b-0042f14e8757
Version: 5
Effective Time: 20130802
 
Sunrise Pharmaceutical Inc