CAREALL SENNA-S LAXATIVE- docusate sodium, 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 Ingredient

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 sudden change 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

AgeStarting DoseMaximum Dosage
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
children 2 to 6 years of age1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

Inactive ingredients

carnauba was, croscarmellos sodium, D and C yellow number 10 aluminum lake, dibasic calcium phosphate dihydrate, FD and C yellow number 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethlene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide

SENS60 Label

CAREALL SENNA-S LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-054
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-054-0224 in 1 CASE04/18/2016
1NDC:51824-054-0160 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 finalpart33404/18/201606/01/2022
Labeler - New World Imports, Inc. (075372276)

Revised: 10/2020
Document Id: 5bd25827-7ddd-40e8-a6a5-80dafd40c452
Set id: 42273ecf-6245-4fb3-87d4-d41d509b10d8
Version: 3
Effective Time: 20201020
 
New World Imports, Inc.