0339-major

0339-major
SPL v9
SPL
SPL Set ID bee100da-b9c9-4261-b6e6-7b3db5715625
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Silicon Dioxide Caramel Cellulose, Microcrystalline Crospovidone Hypromelloses Magnesium Stearate Polyethylene Glycol 400 Sodium Lauryl Sulfate Talc Light Mineral Oil Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: CPC;339 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-01
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: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

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

MAJOR®

NDC 0904-2500-91

*compare to the active ingredient in FiberCon®

fiber-tabs

calcium polycarbophil 625 mg

bulk-forming laxative

  • safe and effective relief of occasional constipation
  • promotes regularity

90 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.
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, and talc

Questions Or Comments?

Call 1-800-231-4670 Monday-Friday 9AM-5PM EST

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 Fiber-Tabs 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: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

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 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

MAJOR®

NDC 0904-2500-91

*compare to the active ingredient in FiberCon®

fiber-tabs

calcium polycarbophil 625 mg

bulk-forming laxative

  • safe and effective relief of occasional constipation
  • promotes regularity

90 caplets

Section 55105-1 (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.
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, and talc

Questions Or Comments? (Questions or comments?)

Call 1-800-231-4670 Monday-Friday 9AM-5PM EST

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 Fiber-Tabs two or more hours before or after other drugs. All laxatives may affect how other drugs work.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:26.590599 · Updated: 2026-03-14T23:10:53.901398