OTC Medication Information: Laxative

LAXATIVE- bisacodyl tablet, delayed release
GREENBRIER INTERNATIONAL, INC.

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.

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

• for 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
• you may have stomach discomfort, faintness and 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 (1-800-222-1222) 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	take 1 tablet in a single daily dose
children under 6 years	ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 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, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

COMPARE TO ACTIVE INGREDIENT IN
DULCOLAX® LAXATIVE TABLETS*

ASSURED ™

Laxative

• Bisacodyl USP, 5 mg
Stimulant Laxative

Gentle, Dependable, Constipation Relief

Actual Size

Comfort Coated

25 Tablets

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

*This product is not manufactured or distributed
by Sanofi-Aventis Deutschland GMBH, owner of the
registered trademark Dulcolax® Laxative Tablets.
50844 REV0119A32756

DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

Assured 44-327

LAXATIVE bisacodyl tablet, delayed release

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0327 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED Polyvinyl Acetate Phthalate POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE WATER 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 5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:33992-0327-6 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (33992-0327-6)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/25/2002

Labeler — GREENBRIER INTERNATIONAL, INC. (610322518)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	manufacture (33992-0327), pack (33992-0327)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (33992-0327), pack (33992-0327)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	manufacture (33992-0327)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (33992-0327)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		117025878	manufacture (33992-0327)

Revised: 04/2023 GREENBRIER INTERNATIONAL, INC.