GENTLE LAXATIVE- bisacodyl tablet, delayed release

Gentle Laxative by

Drug Labeling and Warnings

Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by BETTER LIVING BRANDS LLC., Time Cap Labs Inc., TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

PURPOSE

Purpose

Stimulant laxative

INDICATIONS & USAGE

Uses

• for relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6-12 hours

WARNINGS

Warnings

DO NOT USE

Do not use

• if you cannot swallow without chewing

ASK DOCTOR

Ask a doctor before use if you have

• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks

WHEN USING

When using this product

• it may cause stomach discomfort, faintness and cramps
• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk

STOP USE

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, 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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• take with a glass of water

• adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose
• children 6 to under 12 years of age:

  1 tablet in a single daily dose

• children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• each tablet contains: magnesium 5 mg
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
• protect from excessive humidity

INACTIVE INGREDIENT

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

QUESTIONS

Questions or comments? 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-410
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ACACIA (UNII: 5C5403N26O)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-410-52	1 in 1 CARTON	06/01/2023
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 21130-410-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/2023

Labeler - BETTER LIVING BRANDS LLC. (009137209)

Registrant - Time Cap Labs Inc. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(21130-410)