FDA.reportPublic FDA data

Fiber Lax

Manufacturer
REMEDYREPACK INC.
Effective date
2022-08-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:55:49

Label at a glance#

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Calcium polycarbophil 625 mg
(equivalent to polycarbophil 500 mg)

Purpose

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 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-Lax two or more hours before or after other drugs. 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 tablets 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 this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning

• dosage will vary according to diet, exercise, previous laxative use or severity of constipation

• continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years and over2 tablets, 1 to 4 times per day
children under 12 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

• each tablet contains: calcium 140 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 silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Fiber Lax

GENERIC: Calcium Polycarbophil

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1610-0

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: CPC;339

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CALCIUM POLYCARBOPHIL 625mg in 1

INACTIVE INGREDIENT(S):

  • CARAMEL
  • CROSPOVIDONE
  • HYPROMELLOSES
  • TALC
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • LIGHT MINERAL OIL
  • POLYETHYLENE GLYCOL 400
  • SILICON DIOXIDE
  • SODIUM LAURYL SULFATE
  • STEARIC ACID

MM1MM1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-4306-05EA - Each0536-4306463c1279-6853-4f79-912a-8572fd9cc5cb12012-07-24
0536-4306-08EA - Each0536-43060195b521-a1e1-41ec-8d0b-23b27de41bb112012-07-24
0536-4306-11EA - Each0536-43068919242e-6c8d-4c4a-83bc-af8ed23ccb9612012-07-24

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
70518-161070518-1610-0
0536-4306

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
ndc (product): 0536-4306
079f4aa1-a841-9d25-e063-6394a90a8a3be691a39c-6a2b-46cc-ba1a-ae90ba1a6d8a2023-10-13WarningsExact identifier
spl set id: e691a39c-6a2b-46cc-ba1a-ae90ba1a6d8a

Reported adverse events (FAERS/openFDA)#

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