SENNA TIME- sennosides tablet, coated

SENNA TIME by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Each tablet contains: Sennosides 8.6 mg

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

PURPOSE

PURPOSE: LAXATIVE

INDICATIONS & USAGE

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

DOSAGE & 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 (do not exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and over - 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 laxative products for longer than 1 week unless directed by a doctor

INACTIVE INGREDIENT

Inactive Ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA TIME 
sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-080-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/07/2018
2	NDC: 49483-080-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/14/2018
3	NDC: 49483-080-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/14/2012

Labeler - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(49483-080)