Quality Choice Fiber Caplets Calcium Polycarbophil

SPL v2

SPL

SPL Set ID 29dbc831-23c1-487d-902a-9404d9ebe805

Route

ORAL

Published

Effective Date 2025-07-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polycarbophil (625 mg)

Inactive Ingredients

Calcium Carbonate Caramel Crospovidone (120 .mu.m) Hypromellose, Unspecified Microcrystalline Cellulose Maltodextrin Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance

Imprint: RP120 Shape: oval Color: brown Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

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

Medication Information

Warnings and Precautions

Choking Warning: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.

Description

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

U Ses

relieves occasional constipation to help restore and maintain regularity
this product 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 right away at 1-800-222-1222.

Section 50565-1

Keep out of reach of children.

Section 51727-6

calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Section 55105-1

Purpose

Bulk-forming laxative

Drug Fats

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Directions

Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

age	Recommended	Daily maximum
adults & children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician

Other Information

each caplet contains: calcium 125 mg
store at room temperature
protect contents from moisture

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC# 83324-276-90

QUALITY CHOICE ^®

*Compare to the Active ingredients in Fibercon ^®

Fiber Caplets

Calcium Polycarbophil 625 mg

Bulk-Forming

Fiber Laxative

Won’t Cause Gas or Bloating As Effective as Fiber Powders

90 Caplets

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets.

Package label for 90 Caplets

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

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Package Label for 140 Caplets

Ask Your 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 Your Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

U Ses (U ses)

relieves occasional constipation to help restore and maintain regularity
this product generally produces bowel movement in 12 to 72 hours

Warnings and Precautions (34071-1)

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Section 55105-1 (55105-1)

Purpose

Bulk-forming laxative

Drug Fats

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Directions

Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

age	Recommended	Daily maximum
adults & children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician

Other Information (Other information)

each caplet contains: calcium 125 mg
store at room temperature
protect contents from moisture

Questions Or Comments? (Questions or Comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC# 83324-276-90

QUALITY CHOICE ^®

*Compare to the Active ingredients in Fibercon ^®

Fiber Caplets

Calcium Polycarbophil 625 mg

Bulk-Forming

Fiber Laxative

Won’t Cause Gas or Bloating As Effective as Fiber Powders

90 Caplets

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets.

Package label for 90 Caplets

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)

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Package Label for 140 Caplets

Ask Your Doctor Before Use If You Have (Ask your 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 Your Doctor Or Pharmacist Before Use If You Are (Ask your doctor or pharmacist before use if you are)

taking any other drug. Take this product 2 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)

{"U ses": "relieves occasional constipation to help restore and maintain regularity this product generally produces bowel movement in 12 to 72 hours", "34071-1": "Choking Warning: 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.", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "50565-1": "Keep out of reach of children.", "51727-6": "calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.", "55105-1": "Purpose Bulk-forming laxative", "Drug Fats": "Active Ingredient (in each caplet) Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil", "Directions": "Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning). This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. age Recommended Daily maximum adults & children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician", "Other information": "each caplet contains : calcium 125 mg store at room temperature protect contents from moisture", "Questions or Comments?": "1-866-467-2748", "PRINCIPAL DISPLAY PANEL": "NDC# 83324-276-90 QUALITY CHOICE ® *Compare to the Active ingredients in Fibercon ® Fiber Caplets Calcium Polycarbophil 625 mg Bulk-Forming Fiber Laxative Won’t Cause Gas or Bloating As Effective as Fiber Powders 90 Caplets 100% QC SATISFACTION GURANTEED Distributed by C.D.M.A., Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING *This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets. Package label for 90 Caplets", "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": "rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.", "Ask your 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 your doctor or pharmacist before use if you are": "taking any other drug. Take this product 2 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: 2026-02-15T12:06:29.013992 · Updated: 2026-03-14T23:09:16.713853