SENNOSIDES AND DOCUSATE SODIUM tablet, film coated

SENNOSIDES AND DOCUSATE SODIUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients (each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Stool Softener
Stimulant Laxative

INDICATIONS & USAGE

RELIEVES OCCASIONAL CONSTIPATION

GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 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

DOSAGE & ADMINISTRATION

ADULTS AND CHILDREN 12 YEARS AND OVER: 2-4 TABLETS ONCE DAILY OR IN DIVIDED DOSES
CHILDREN 6 TO UNDER 12 YEARS: 1-2 TABLETS ONCE DAILY OR IN DIVIDED DOSES
CHILDREN 2 TO UNDER 6 YEARS; 1/2 -1 TABLET ONCE DAILY OR IN DIVIDED DOSES
CHILDREN UNDER 2 YEARS: ASK A DOCTOR

INACTIVE INGREDIENT

CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SODIUM BENZOATE, STEARIC ACID, TITANIUM DIOXIDE.

KEEP OUT OF REACH OF CHILDREN

kEEP OUT OF REACH OF CHILDREN.  iN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SENNOSIDES AND DOCUSATE SODIUM  
sennosides and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-097
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 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 RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-097-01	100 in 1 BOTTLE, PLASTIC
2	NDC: 49483-097-00	100000 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2010

Labeler - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-097)