FDA.reportPublic FDA data

Fiber Caplets

Manufacturer
Bryant Ranch Prepack
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:05

Label at a glance#

ProductFiber Caplets
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections

Indications and uses

relieves occasional constipation this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning. dosage will vary according to diet, excercise, previous laxative use or severity of constipation. continued use for 1 or 3 days is normally required to provide full benefit.  adults and children 12 years and over                                ...

Storage and handling

each caplet contains: calcium 135mg store at room temperature protect contents from moisture

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
  • this product 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
  • difficulty in swallowing
  • 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 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 if 

OTC - STOP USE SECTION

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
  • continued use for 1 or 3 days is normally required to provide full benefit.
 adults and children 12 years and over                                                                  2 caplets, 1 to 4 times a day                                            
 children under 12 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 135mg
  • store at room temperature
  • protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

HOW SUPPLIED

How Supplied Section

Calcium Polycarbophil 625mg Tablet

  • NDC 71335-1075-1: 30 Tablets in a BOTTLE
  • NDC 71335-1075-2: 60 Tablets in a BOTTLE
  • NDC 71335-1075-3: 120 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Calcium Polycarbophil 625mg Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1075-12025-02-21C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative
71335-1075-22025-02-21C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative
71335-1075-32025-02-21C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative
71335-1075-12024-01-30C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative
71335-1075-22024-01-30C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative
71335-1075-32024-01-30C16284748780-11030e365-3980-111a-e063-dadaa90a10e2Fiber Laxative

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1075FIBER CAPLETS (CALCIUM POLYCARBOPHIL) TABLET [BRYANT RANCH PREPACK]3Legacy NDC20250224_3e0aedef-6bd5-4ee9-b1f4-16a84d396f93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-190-13EA - Each49348-19046a146a7-5a03-4475-854b-4f5d65dfd22212016-09-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-107571335-1075-1, 71335-1075-2, 71335-1075-3
49348-190

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARAMELT9D99G2B1RIACT

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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0772a43d-111d-4fa3-9309-b0f70b3ee6a03e0aedef-6bd5-4ee9-b1f4-16a84d396f932025-01-29WarningsExact identifier
spl id: 0772a43d-111d-4fa3-9309-b0f70b3ee6a0
spl set id: 3e0aedef-6bd5-4ee9-b1f4-16a84d396f93

Reported adverse events (FAERS/openFDA)#

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