Quality Choice 44-327-delisted

Quality Choice 44-327-delisted
SPL v10
SPL
SPL Set ID f5278c7e-def5-4073-a529-bf0d0c9eac9e
Route
ORAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-02-14 Until 2026-05-17

Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
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



Do Not Use

if you cannot swallow without chewing.

Other Information
  • TAMPER EVIDENT: DO NOT USE IS 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

QC®

QUALITY

CHOICE

NDC 63868-572-25

*Compare to the

Active Ingredient in

Dulcolax® Laxative Tablets

Laxative

Bisacodyl USP, 5 mg - Stimulant Laxative

Gentle, Dependable

Constipation Relief

Actual Size

25 Comfort Coated 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

SATISFACTION GUARANTEED

100%QC

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-327
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 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 right away.

Active Ingredient (in Each Tablet)

Bisacodyl USP, 5 mg

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

Structured Label Content

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Purpose

Stimulant laxative

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



Do Not Use (Do not use)

if you cannot swallow without chewing.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IS 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 (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? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-572-25

*Compare to the

Active Ingredient in

Dulcolax® Laxative Tablets

Laxative

Bisacodyl USP, 5 mg - Stimulant Laxative

Gentle, Dependable

Constipation Relief

Actual Size

25 Comfort Coated 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

SATISFACTION GUARANTEED

100%QC

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-327
When Using This Product (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 and cramps
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl USP, 5 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)