LAXATIVE- bisacodyl tablet
Safeway

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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Active ingredient(s)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Use(s)

relieves 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

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

When using this product

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

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

If pregnant 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 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 15°-30°C (59°-86°F)
avoid excessive humidity
see end flap for expiration date and lot number

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 21130-327-56

Compare to

Dulcolax®

active ingredient*

Laxative

Bisacodyl, USP 5 mg

Enteric Coated

Gentle and Effective

• Relieves Occasional

Constipation and Irregularity

• Usually Produces a Bowel Movement in 6 to 12 Hours

ACTUAL SIZE

25 TABLETS

SAFEWAY™

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV0510F32756

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA 94566-0009

QUALITY & SaTISFACTION GUARANTEED OR YOUR MONEY BACK

1-888-SAFEWAY / www.safeway.com

Product Packaging

LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-327
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (BISACODYL)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA
AMMONIA
CALCIUM CARBONATE
CARNAUBA WAX
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
FERROSOFERRIC OXIDE
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POLYDEXTROSE
POLYETHYLENE GLYCOL
POVIDONE
PROPYLENE GLYCOL
PROPYLPARABEN
SHELLAC
DIMETHICONE
SODIUM ALGINATE
SODIUM BENZOATE
SODIUM BICARBONATE
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	44;327
Contains

Packaging
#	Item Code	Package Description
1	NDC:21130-327-56	1 in 1 CARTON
1		25 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/25/2002

Labeler - Safeway (009137209)

Revised: 06/2011

Document Id: fd856fa6-f7f0-4273-b909-35a500cd4427

Set id: 6904f1f7-7b37-44fa-a2e6-cec4c97a9a4b

Version: 5

Effective Time: 20110609

Safeway