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
(click image for full-size original)

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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