LAXATIVE- bisacodyl tablet
Allegiant Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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226 - Health A2Z Bisacodyl 5mg

Active Ingredient (in each tablet)

Bisacodyl USP 5mg

Purpose

Stimulant Laxative

Uses

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

Warnings

Do not use

if you cannot swallow without chewing.

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 this product

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

Stop use and ask a doctor if

you have rectal bleeding or no 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

If pregnant 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 accidental overdose, get medical help or contact a doctor or Poison Control Center

(1-800-222-1222) right away.

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 information

store between 68º to 77ºF (20º to 25ºC)
do not use blister unit is broken or torn

Inactive ingredients

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

Principal Display Panel

HealthA2Z®

*Compare To Ducolax® Active Ingredients

Laxative

Bisacodyl 5mg

Gentle & Effective

Overnight Relief

Enteric Coated

TABLETS

Bisacodyl 5mg Tablets

LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-226
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUGARCANE (UNII: 81H2R5AOH3)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69168-226-92	25 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/23/2014	08/31/2020
2	NDC:69168-226-03	250 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/23/2014	08/31/2020

Labeler - Allegiant Health (079501930)

Revised: 11/2017

Document Id: 3c7b86c4-d6c8-441a-9a0c-6c9499fd2b0e

Set id: b5d0bdf6-d934-4d79-bc66-5c25c1bfe99c

Version: 7

Effective Time: 20171116

Allegiant Health