DOCUSATE SODIUM - SENNOSIDES by CARDINAL HEALTH / TIME CAP LABORATORIES, INC LEADER 243R

DOCUSATE SODIUM - SENNOSIDES by

Drug Labeling and Warnings

DOCUSATE SODIUM - SENNOSIDES by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM - SENNOSIDES- docusate sodium - sennosides tablet, film coated 
CARDINAL HEALTH

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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LEADER 243R

ACTIVE iNGREDIENTS (IN EACH TABLET)

Docusate sodium 50 mg

Sennosides 8.6 mg

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center (1-800 222-1222) right away.

Purpose:

Stool softener

Stimulant laxative

Uses:

Relieves occasional constipation (irregularity)

Generally produces bowel movement in 6 to 12 hours

Warnings:

Do not use:

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

If you are presently taking mineral oil, unless directed by a doctor

Directions:

Take only my mouth, Doses may be taken as a single daily dose, prefeably in the evening, or in divided doses.

Adults and children 12 years of age and older: take 2-4 tablets daily

Childreen 6 to under 12 years: take 1-2 tablets daily

Children 2 to under 6 years: take up to 1 talet daily

Children under 2 years: ask a doctor

image description

DOCUSATE SODIUM - SENNOSIDES 
docusate sodium - sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0229
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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)  
Product Characteristics
Colorpurple (BURGUNDY) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0229-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/201712/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/27/201712/27/2019
Labeler - CARDINAL HEALTH (097537435)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(70000-0229)

Revised: 12/2019
 
CARDINAL HEALTH