Leader 44-327

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 Aluminum Lake 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 Active Since 2002-03-25

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
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

LEADER_™

NDC 70000-0221-3

Gentle

Laxative

Bisacodyl USP, 5 mg | Stimulant Laxative

Gentle, Dependable

Constipation Relief

175 ENTERIC COATED

TABLETS

Actual Size

COMPARE TO

DULCOLAX®

LAXATIVE TABLETS

active ingredient*

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE

IF PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

All LEADER™ Brand

Products Have A

100%

Money Back

Guarantee

Return to place of

purchase if not satisfied.

*This product is not manufactured or distributed by A. Nattermann

& Cie. GmbH, owner of the registered trademark Dulcolax®

Laxative Tablets. 50844 REV0923B32733

CardinalHealth™

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

© 2023 Cardinal Health. All Rights

Reserved. CARDINAL HEALTH, the

Cardinal Health LOGO, LEADER, and

the Leader LOGO are trademarks or

registered trademarks of Cardinal

Health. All other marks are the

property of their respective

owners.

Leader 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
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

LEADER_™

NDC 70000-0221-3

Gentle

Laxative

Bisacodyl USP, 5 mg | Stimulant Laxative

Gentle, Dependable

Constipation Relief

175 ENTERIC COATED

TABLETS

Actual Size

COMPARE TO

DULCOLAX®

LAXATIVE TABLETS

active ingredient*

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE

IF PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

All LEADER™ Brand

Products Have A

100%

Money Back

Guarantee

Return to place of

purchase if not satisfied.

*This product is not manufactured or distributed by A. Nattermann

& Cie. GmbH, owner of the registered trademark Dulcolax®

Laxative Tablets. 50844 REV0923B32733

CardinalHealth™

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

© 2023 Cardinal Health. All Rights

Reserved. CARDINAL HEALTH, the

Cardinal Health LOGO, LEADER, and

the Leader LOGO are trademarks or

registered trademarks of Cardinal

Health. All other marks are the

property of their respective

owners.

Leader 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

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Raw Label Data

All Sections (JSON)

{"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": "if you cannot swallow without chewing. ", "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": "LEADER ™ NDC 70000-0221-3 Gentle Laxative Bisacodyl USP, 5 mg | Stimulant Laxative Gentle, Dependable Constipation Relief 175 ENTERIC COATED TABLETS Actual Size COMPARE TO DULCOLAX® LAXATIVE TABLETS active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. *This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the registered trademark Dulcolax® Laxative Tablets. 50844 REV0923B32733 Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 © 2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Leader 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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information