Quality Choice 44-676a

Quality Choice 44-676a
SPL v2
SPL
SPL Set ID 8bbc8ad6-4508-431a-a547-c11c3129243d
Route
ORAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Aluminum Lake Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Shellac Dimethicone Water Sodium Bicarbonate Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours
Directions
  • do not take more than directed
  • 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 IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive humidity

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 83324-033-30

Gentle Laxative

Bisacodyl USP, 5 mg - Stimulant Laxative

Gentle, Dependable

Constipation Relief

Actual

Size

30 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

50844    REV0923A67601

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-676A
When Using This Product
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause 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 (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours
Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • 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 IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive humidity

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 83324-033-30

Gentle Laxative

Bisacodyl USP, 5 mg - Stimulant Laxative

Gentle, Dependable

Constipation Relief

Actual

Size

30 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

50844    REV0923A67601

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-676A
When Using This Product (When using this product)
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause 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

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