Konsyl Fiber

Manufacturer
Konsyl Pharmaceuticals, Inc.
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:59:43

Label at a glance#

ProductKonsyl Fiber
Active ingredientCALCIUM POLYCARBOPHIL
Label structure7 sections

Indications and uses

• relieves occasional constipation • promotes regularity • this product generally produces a bowel movement in 12 to 72 hours

Dosage and administration

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 laxative 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.  adults and children 12 years ...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Polycarbophil 625 mg (equivalent to 500 mg polycarbophil)

Purpose

OTC - PURPOSE SECTION

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation • promotes regularity • this product generally produces a bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

When using this product

OTC - WHEN USING SECTION

• 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 

OTC - STOP USE SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 laxative 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.

 adults and children 12
years of age and older
 Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor
 children under 12 years of age consult a doctor

Other information

SPL UNCLASSIFIED SECTION

• each caplet contains: calcium 138 mg
• store at controlled room temperature, 68°F-77°F (20°C-25°C)
• protect contents from moisture 

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

caramel, cellulose, crospovidone, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium lauryl sulfate, stearic acid. May also contain calcium carbonate, croscarmellose sodium, maltodextrin, talc.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New LabelNew Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0224-18890224-1889-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b78c994d-415f-0330-e053-2995a90ad5654305c136-4e34-4aea-a105-341e6dd319e72020-12-28WarningsExact identifier
spl id: b78c994d-415f-0330-e053-2995a90ad565
spl set id: 4305c136-4e34-4aea-a105-341e6dd319e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.