EXTRA GENTLE LAXATIVE- bisacodyl tablet, delayed release

Extra Gentle Laxative by

Drug Labeling and Warnings

Extra Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP 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 temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 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
• a sudden change in bowel habits that lasts more than 2 weeks
  

WHEN USING

When using this product

• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• you may have stomach discomtort, faintness or cramps
  

STOP USE

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.

DOSAGE & ADMINISTRATION

Directions

• take with a glass of water

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

OTHER INFORMATION

Other information

• each tablet contains: magnesium 5 mg
• store at 25 0C (77 0F) excursions permitted between 15 0C-30 0C (59 0-86 0F)
• 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? Call 1-888-309-9030

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA GENTLE LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-954
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)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
ACACIA (UNII: 5C5403N26O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
INVERT SUGAR (UNII: ED959S6ACY)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-954-52	1 in 1 CARTON	07/24/2021
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/24/2021

Labeler - DOLGENCORP INC (068331990)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(55910-954)