FDA.reportPublic FDA data

FIBER TABS

Manufacturer
Major Pharmaceuticals
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:19:30

Label at a glance#

ProductFIBER TABS
Active ingredientCALCIUM POLYCARBOPHIL
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

OTC - PURPOSE SECTION

Purpose

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces 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 if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take Fiber-Tabs two 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 if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 over2 caplets, 1 to 4 times per day
children under 12 years of ageask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

*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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Major labelMajor label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN9
284308Fiber Tab 625 MG Oral TabletPSN9
284308calcium polycarbophil 625 MG Oral Tablet [Fiber Tab]SBD9
308934calcium polycarbophil 625 MG Oral TabletSCD9
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY9
284308Fiber Tab 625 MG Oral TabletSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309042500913GTIN-13: 0309042500913
EAN-13: 0309042500913
GTIN-12: 309042500913
UPC-A: 309042500913
GTIN storage (14 digits): 00309042500913		0339-90G-Major-A3_LBL-R53988.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2500-91FIBER TABS90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2500-91EA - Each0904-25007a5bbbbb-bd50-41f4-a837-42d180545d8b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY492
POLYCARBOPHILACTIVE MOIETYW25LM17A4W2
12-HYDROXYSTEARIC ACIDINACTIVE INGREDIENT933ANU3H2S2
CARAMELINACTIVE INGREDIENTT9D99G2B1R2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSPOVIDONEINACTIVE INGREDIENT68401960MK2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP2
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N92
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-25000904-2500-91

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CARAMELT9D99G2B1RIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
LIGHT MINERAL OILN6K5787QVPIACT
STEARIC ACID4ELV7Z65APIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, FILM COATED / ORAL33.7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, FILM COATED / ORAL33.7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
ndc (package): 0904-2500-91
ndc (product): 0904-2500
ndc11 (package): 00904250091
spl id: 44fe77d2-515f-0753-e063-6394a90a62f2
spl set id: bee100da-b9c9-4261-b6e6-7b3db5715625

Reported adverse events (FAERS/openFDA)#

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