0339-cardinal

SPL v6

SPL

SPL Set ID b4637e18-c65f-0e81-e053-2a95a90a2284

Route

ORAL

Published

Effective Date 2025-11-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polycarbophil (625 mg)

Inactive Ingredients

Microcrystalline Cellulose Light Mineral Oil Sodium Lauryl Sulfate Magnesium Stearate Polyethylene Glycol 400 Stearic Acid Talc Silicon Dioxide Crospovidone Hypromelloses Caramel

Identifiers & Packaging

Pill Appearance

Imprint: CPC;339 Shape: oval Color: white Size: 19 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-11-18

Description

Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Medication Information

Description

Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, owner of the registered trademark Fibercon®.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

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

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Section 50565-1

Keep out of reach of children.

Section 51945-4

LEADER

NDC 70000-0067-1

Fiber Laxative + Calcium

Calcium Polycarbophil, 625 mg

Bulk-Forming Laxative

Fiber Therapy for Regularity

COMPARE TO FIBERCON® active ingredient*

250 Caplets

Section 55105-1

Purpose

Bulk-forming laxative

Warnings

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Directions

take each dose of this product with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

dosage will vary according to diet, exercise, previous laxative use or severity of constipation

continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years of age and over	2 caplets, 1 to 4 times per day
children under 12 years of age	ask a doctor

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Other Information

 each caplet contains: calcium 125 mg

do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)

protect contents from moisture

Inactive Ingredients

caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid, talc.

Questions Or Comments?

1-800-231-4670

When Using This Product

do not use for more than 7 days unless directed by a doctor

do not take more than 8 caplets in a 24-hour period unless directed by a doctor

Stop Use and Ask A Doctor If

you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

abdominal pain, nausea, or vomiting

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. Take this product two or more hours before or after other drugs. All laxatives may affect how other drugs work.

Structured Label Content

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, owner of the registered trademark Fibercon®.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

LEADER

NDC 70000-0067-1

Fiber Laxative + Calcium

Calcium Polycarbophil, 625 mg

Bulk-Forming Laxative

Fiber Therapy for Regularity

COMPARE TO FIBERCON® active ingredient*

250 Caplets

Section 55105-1 (55105-1)

Purpose

Bulk-forming laxative

Warnings

Directions

adults and children 12 years of age and over	2 caplets, 1 to 4 times per day
children under 12 years of age	ask a doctor

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Other Information (Other information)

 each caplet contains: calcium 125 mg

do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)

protect contents from moisture

Inactive Ingredients (Inactive ingredients)

caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid, talc.

Questions Or Comments? (Questions or comments?)

1-800-231-4670

When Using This Product (When using this product)

do not use for more than 7 days unless directed by a doctor

do not take more than 8 caplets in a 24-hour period unless directed by a doctor

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

you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.

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

abdominal pain, nausea, or vomiting

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. Take this product two or more hours before or after other drugs. All laxatives may affect how other drugs work.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "42229-5": "*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, owner of the registered trademark Fibercon®. DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2025 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners. WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.", "50565-1": "Keep out of reach of children.", "51945-4": "LEADER NDC 70000-0067-1 Fiber Laxative + Calcium Calcium Polycarbophil, 625 mg Bulk-Forming Laxative Fiber Therapy for Regularity COMPARE TO FIBERCON® active ingredient* 250 Caplets", "55105-1": "Purpose Bulk-forming laxative", "Warnings": "Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.", "Directions": "take each dose of this product with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children 12 years of age and over 2 caplets, 1 to 4 times per day children under 12 years of age ask a doctor", "Drug Facts": "Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)", "Other information": " each caplet contains : calcium 125 mg do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F) protect contents from moisture", "Inactive ingredients": "caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid, talc.", "Questions or comments?": "1-800-231-4670", "When using this product": "do not use for more than 7 days unless directed by a doctor do not take more than 8 caplets in a 24-hour period unless directed by a doctor", "Stop use and ask a doctor if": "you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.", "Ask a doctor before use if you have": "abdominal pain, nausea, or vomiting 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. Take this product two or more hours before or after other drugs. All laxatives may affect how other drugs work."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.545830 · Updated: 2026-03-14T23:13:29.977510