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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0229
Route of Administration	ORAL

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)
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
Color	purple (BURGUNDY)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL131
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0229-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2017	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/27/2017	12/27/2019

Labeler - CARDINAL HEALTH (097537435)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(70000-0229)

Revised: 12/2019

Document Id: 98cf8599-b67f-fc6f-e053-2a95a90ac7ee

34390-5

Set id: fa0f005b-bc52-4788-ae4c-2a05ab0023ab

Version: 2

Effective Time: 20191203

 

CARDINAL HEALTH