leader 44-347

leader 44-347
SPL v11
SPL
SPL Set ID 33a5d4f9-9e5a-4392-8599-ed4319cf5ff4
Route
oral
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (15 mg)
Inactive Ingredients
acacia calcium carbonate carnauba wax starch, corn dibasic calcium phosphate dihydrate ferrosoferric oxide ferric oxide red ferric oxide yellow magnesium stearate methylparaben microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified propylene glycol propylparaben shellac silicon dioxide sodium benzoate sodium lauryl sulfate sucrose talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;347 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-03-01

Purpose

Stimulant laxative

Description

Sennosides USP, 15 mg


Medication Information

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 6 to 12 hours

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew
adults and children 12

years and over
2 tablets once or

twice daily
children 6 to under

12 years
1 tablet once or

twice daily
children under 6 years ask a doctor


Other Information
  • each tablet contains: calcium 45 mg
  • 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)
  • see end flap for expiration date and lot number
Inactive Ingredients

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Description

Sennosides USP, 15 mg

Principal Display Panel

LEADER

NDC 70000-0443-1

Regular Strength

Laxative

Sennosides USP, 15 mg

Stimulant Laxative

Gentle, Dependable

Constipation Relief

30 TABLETS

Actual Size

COMPARE TO

ex•lax® REGULAR

STRENGTH

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

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark ex•lax® Regular Strength.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

© 2025 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.

50844   REV0824B34701

100% Money Back Guarantee

Return to place of purchase.

Leader 44-347
Do Not Use
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for a period longer than 1 week unless directed by a doctor
Questions Or Comments?

1-800-426-9391

Stop Use and Ask A Doctor If

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

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)

Sennosides USP, 15 mg

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 6 to 12 hours

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew
adults and children 12

years and over
2 tablets once or

twice daily
children 6 to under

12 years
1 tablet once or

twice daily
children under 6 years ask a doctor


Other Information (Other information)
  • each tablet contains: calcium 45 mg
  • 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)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Principal Display Panel (Principal display panel)

LEADER

NDC 70000-0443-1

Regular Strength

Laxative

Sennosides USP, 15 mg

Stimulant Laxative

Gentle, Dependable

Constipation Relief

30 TABLETS

Actual Size

COMPARE TO

ex•lax® REGULAR

STRENGTH

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

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark ex•lax® Regular Strength.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

© 2025 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.

50844   REV0824B34701

100% Money Back Guarantee

Return to place of purchase.

Leader 44-347
Do Not Use (Do not use)
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for a period longer than 1 week unless directed by a doctor
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

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))

Sennosides USP, 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.


Advanced Ingredient Data


Raw Label Data

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