Laxative by Hy-Vee DRUG FACTS

Laxative by

Drug Labeling and Warnings

Laxative by is a Otc medication manufactured, distributed, or labeled by Hy-Vee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAXATIVE ENTERIC COATED- bisacodyl tablet, coated 
Hy-Vee

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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DRUG FACTS

Active ingredient (in each enteric coated tablet)

 Bisacodyl, USP 5 mg

Purpose

 Stimulant laxative

Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces a 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)
• it may cause stomach discomfort, faintness and cramps
• do not use within 1 hour after taking an antacid or milk

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 pregnancy or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take with a glass of water

• adults and children 12 years of age 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

• store at controlled room temperature 15º-30ºC (59º-86ºF)

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, and titanium dioxide

Questions or comments?

Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

Overnight Relief

Laxative Tablets

Stimulant laxative

Gentle yet effective

Bisacodyl, 5 mg

*Compare to DULCOLAX® active ingredient

Enteric Coated Tablets

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, owner of the registered trademark Dulcolax®

Product Label

Bisacodyl 5 mg tablet

LAXATIVE  ENTERIC COATED
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-086
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
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
SUCROSE (UNII: C151H8M554)
POVIDONE (UNII: FZ989GH94E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALUMINUM OXIDE (UNII: LMI26O6933)

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: 42507-086-63	1 in 1 CARTON	11/08/2010	12/31/2019
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	11/08/2010	12/31/2019

Labeler - Hy-Vee (006925671)

Revised: 12/2018

Document Id: 15f8309c-2ee0-4360-a60c-f4fd3dbc62f1

34390-5

Set id: 0530439e-a409-49c0-9778-ac9dde7dcc10

Version: 2

Effective Time: 20181220

 

Hy-Vee