Senna S by Care One (American Sales Company) / P & L Development, LLC DRUG FACTS

Senna S by

Drug Labeling and Warnings

Senna S by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA S- docusate sodium and sennosides tablet 
Care One (American Sales Company)

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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DRUG FACTS

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warnings

Do not use

  • if you are now 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
  • noticed a sudden change in bowel habits that continues over a period of 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 may indicate 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

  • take preferably at bedtime or as directed by a doctor
 age starting dosage maximum dosage
 adults and children 12 years of age or older2 tablets
once a day
4 tablets
twice a day
 children 6 to under 12 years1 tablet
once a day
2 tablets
twice a day
 children 2 to under 6 years1/2 tablet
once a day
1 tablet
twice a day
 children under 2 years ask a doctor ask a doctor

Other Information

  • each tablet contains: sodium 6 mg/tablet LOW SODIUM
  • each tablet contains: Calcium 20 mg/tablet
  • store at 15o- 30o C (59o-86o F) in well closed containers
  • do not use if imprinted safety seal under cap is broken or missing
  • **This product is not manufactured or distributed by Purdue products L.P., owner of the registered trademark Senokot-S®

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredients in Senokot- S® **

SENNA-S

Laxative/ Stool softener

Standardized senna concentrate 8.6 mg and Docusate Sodium 50 mg

Natural vegetable laxative ingredient plus stool softener

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: American Sales Company

4201 Walden avenue, Lancaster, NY 14086

www.care1.com

Product Label

CareOne

Senna-S Laxative/stool softener

SENNA S 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41520-182
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, 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)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL081;SS1;S35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41520-182-601 in 1 BOX07/15/201001/01/2020
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/15/201001/01/2020
Labeler - Care One (American Sales Company) (809183973)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2012
 
Care One (American Sales Company)