STOOL SOFTENING SENNA LAXATIVE- sennosides 8.6 mg - docusate sodium 50 mg tablet

STOOL SOFTENING SENNA LAXATIVE by

Drug Labeling and Warnings

STOOL SOFTENING SENNA LAXATIVE by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC., TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Each Tablet contains:

Docusate sodium 50 mg

Sennosides 8.6 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake, fd&c yellow#6 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

INDICATIONS AND USAGE

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

PURPOSE

Stimulant Laxative and Stool Softener

DOSAGE AND ADMINISTRATION

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day

Children 6 to under 12 years: - Starting dosage: 1 tablet once a day-Maximum dosage: 2 tablets twice a day

Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

WARNINGS

WARNINGS:

Do not use this product

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

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

PREGNANT OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

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

INGREDIENTS AND APPEARANCE

STOOL SOFTENING SENNA LAXATIVE 
sennosides 8.6 mg - docusate sodium 50 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-192
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 A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-192-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/29/2019

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(11673-192)