SENNA-S LAXATIVE- docusate sodium and sennosides tablet 
New World Imports, 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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Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

Warnings

Do not use:

​This product is you are presently taking mineral oil, unless directed by a doctor. 

Laxative products for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have:

Stomach pain, nausea, vomiting, a suddenc hange in bowel movements that persists over 2 weeks

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.

Keep out of reach of children.

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

Directions

Age Starting Dose Maximum Dosage
adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day
children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Other information

Inactive ingredients

carnauba wax*, croscarmellose sodium, DandC Yellow 10 Aluminum Lake, dibasic calcium phosphate dihydrate, FDandC Blue 2 Aluminum Lake*, FDandC Red 40 Aluminum Lake*, FDandC Yellow 6 Aluminum Lake, hypromellose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, sodium benzoate*, stearic acid, titanium dioxide

*may also contain

label.jpg

SENNA-S LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-026
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color orange Score no score
Shape ROUND Size 9mm
Flavor Imprint Code TCL081
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51824-026-01 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 12/01/2012
Labeler - New World Imports, Inc. (075372276)

Revised: 4/2015
Document Id: d006294e-3a0b-4091-9a71-6e08e613364b
Set id: 9928dac7-5513-4a92-a6f4-ffe7ac1bc8f5
Version: 5
Effective Time: 20150406
 
New World Imports, Inc.