LAXATIVE- bisacodyl tablet
Rite Aid

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 (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

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

Rite Aid®
PHARMACY

*Compare to the active ingredient in Dulcolax®

LAXATIVE
bisacodyl USP 5 mg
stimulant laxative

gentle, predictable over night relief
delayed-release tablets
enteric coated

100 TABLETS
5 mg EACH

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

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.

50844 REV1011A32712

DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

Rite Aid 44-327

LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0327
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 GLYCOLS
POVIDONES
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:11822-0327-5	1 in 1 CARTON
1		50 in 1 BLISTER PACK
2	NDC:11822-0327-1	1 in 1 CARTON
2		100 in 1 BOTTLE, PLASTIC

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

Labeler - Rite Aid (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-0327)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11822-0327)

Revised: 10/2012

Document Id: 2adece12-21aa-4360-a70c-6caebd527937

Set id: 109fe63a-aca3-42b5-8074-673fba5ae2eb

Version: 5

Effective Time: 20121001

Rite Aid