LAX-TIME- sennosides tablet, sugar coated

LAX-TIME by

Drug Labeling and Warnings

LAX-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:

CALCIUM SENNOSIDES 25 mg

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide

PURPOSE

stool softner, laxative

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 (not to 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 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

INDICATIONS & USAGE

Uses:

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.

195R Lax-Time (Sennosides) 25 mg

INGREDIENTS AND APPEARANCE

LAX-TIME 
sennosides tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-083
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	25 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STEARIC ACID (UNII: 4ELV7Z65AP)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
RAW SUGAR (UNII: 8M707QY5GH)
TALC (UNII: 7SEV7J4R1U)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL083
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-083-00	50000 in 1 CARTON; Type 0: Not a Combination Product	08/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/30/2018

Labeler - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(49483-083)