Major 44-327a-unit Dose

Major 44-327a-unit Dose
SPL v20
SPL
SPL Set ID 4fb4e630-875f-4c82-86d9-7696857e3c42
Route
ORAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Carbonate Carnauba Wax Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Ferrosoferric Oxide Anhydrous Lactose Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Methylparaben Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Propylparaben Shellac Dimethicone Water Sodium Benzoate Sodium Bicarbonate Sodium Lauryl Sulfate 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 Active Since 2002-03-25
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
  • 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
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

acacia, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methylparaben, polydextrose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, propylparaben, shellac glaze, simethicone, sodium benzoate, sodium bicarbonate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 0904-6407-61

MAJOR®

compare to the active ingredient

in Dulcolax® Laxative Tablets*

bisacodyl

USP

bisacodyl USP, 5 mg

stimulant laxative

gentle, dependable constipation relief

enteric coated

100 tablets

(10 x 10) unit dose

comfort coated

tablets

actual size

*This product is not manufactured or distributed by

A. Nattermann & Cie. GmbH, owner of the registered

trademark Dulcolax® Laxative Tablets.

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 ORG042532712

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Major 44-327
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
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

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
  • 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
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

acacia, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methylparaben, polydextrose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, propylparaben, shellac glaze, simethicone, sodium benzoate, sodium bicarbonate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 0904-6407-61

MAJOR®

compare to the active ingredient

in Dulcolax® Laxative Tablets*

bisacodyl

USP

bisacodyl USP, 5 mg

stimulant laxative

gentle, dependable constipation relief

enteric coated

100 tablets

(10 x 10) unit dose

comfort coated

tablets

actual size

*This product is not manufactured or distributed by

A. Nattermann & Cie. GmbH, owner of the registered

trademark Dulcolax® Laxative Tablets.

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 ORG042532712

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Major 44-327
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)
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:19.263941 · Updated: 2026-03-14T23:12:21.703136