Gendose - Fiber Laxative Caplets (77333-120)

Gendose - Fiber Laxative Caplets (77333-120)
SPL v6
SPL
SPL Set ID e7f3b91b-7942-3e0d-e053-2a95a90a34ee
Route
ORAL
Published
Effective Date 2022-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Hypromellose, Unspecified Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Silicon Dioxide Calcium Carbonate Magnesium Stearate Maltodextrin Crospovidone Microcrystalline Cellulose Caramel

Identifiers & Packaging

Pill Appearance
Imprint: RP120 Shape: oval Color: brown Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-02
Description

CALCIUM POLYCARBOPHIL 625 MG (EQUIVALENT TO 500 MG POLYCARBOPHIL)

Purpose

BULK-FORMING LAXATIVE

Medication Information

Purpose

BULK-FORMING LAXATIVE

Description

CALCIUM POLYCARBOPHIL 625 MG (EQUIVALENT TO 500 MG POLYCARBOPHIL)

Uses
  • RELIEVES OCCASIONAL CONSTIPATION TO HELP RESTORE AND MAINTAIN REGULARITY
  • THIS PRODUCT GENERALLY PRODUCES BOWEL MOVEMENT IN 12 TO 72 HOURS
Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY 1-800-222-1222.

Section 51945-4

Warnings

CHOKING: TAKING THIS PRODUCT WITHOUT ADEQUATE FLUID MAY CAUSE IT TO SWELL AND BLOCK YOUR THROAT OR ESAPHAGUS AND MAY CAUSE CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE DIFFICULATY 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

  • ADBOMINAL PAIN, NAUSEA, OR VOMITING
  • A SUDDEN CHANGE IN BOWEL HABITS THAT PERSIST OVER A PERIOD OF 2 WEEKS

ASK A 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 DRUGS WORK.

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 LAXATIVES. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

Directions
  • TAKE EACH DOSE 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

ADULTS AND CHILDREN OVER 12 YEARS: 2 CAPLETS ONCE A DAY; UP TO 4 TIMES A DAY.

CHILDREN UNDER 12 YEARS: ASK A DOCTOR

Other Information
  • EACH CAPLET CONTAINS: CALCIUM 125MG
  • STORE AT ROOM TEMPERATURE
  • PROTECT CONTENTS FROM MOISTURE
Inactive Ingredients

CALCIUM CARBONATE, CARAMEL COLOR, CROSPOVIDONE, HYPROMELLOSE, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SILICON DIOXIDE, SODIUM LAURYL SULFATE

Active Ingredient (in Each Caplet)

CALCIUM POLYCARBOPHIL 625 MG

(EQUIVALENT TO 500 MG POLYCARBOPHIL)

Structured Label Content

Uses (USES)
  • RELIEVES OCCASIONAL CONSTIPATION TO HELP RESTORE AND MAINTAIN REGULARITY
  • THIS PRODUCT GENERALLY PRODUCES BOWEL MOVEMENT IN 12 TO 72 HOURS
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY 1-800-222-1222.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

BULK-FORMING LAXATIVE

Warnings (WARNINGS)

CHOKING: TAKING THIS PRODUCT WITHOUT ADEQUATE FLUID MAY CAUSE IT TO SWELL AND BLOCK YOUR THROAT OR ESAPHAGUS AND MAY CAUSE CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE DIFFICULATY 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

  • ADBOMINAL PAIN, NAUSEA, OR VOMITING
  • A SUDDEN CHANGE IN BOWEL HABITS THAT PERSIST OVER A PERIOD OF 2 WEEKS

ASK A 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 DRUGS WORK.

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 LAXATIVES. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

Directions (DIRECTIONS)
  • TAKE EACH DOSE 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

ADULTS AND CHILDREN OVER 12 YEARS: 2 CAPLETS ONCE A DAY; UP TO 4 TIMES A DAY.

CHILDREN UNDER 12 YEARS: ASK A DOCTOR

Other Information (OTHER INFORMATION)
  • EACH CAPLET CONTAINS: CALCIUM 125MG
  • STORE AT ROOM TEMPERATURE
  • PROTECT CONTENTS FROM MOISTURE
Inactive Ingredients (INACTIVE INGREDIENTS)

CALCIUM CARBONATE, CARAMEL COLOR, CROSPOVIDONE, HYPROMELLOSE, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SILICON DIOXIDE, SODIUM LAURYL SULFATE

Active Ingredient (in Each Caplet) (ACTIVE INGREDIENT (IN EACH CAPLET))

CALCIUM POLYCARBOPHIL 625 MG

(EQUIVALENT TO 500 MG POLYCARBOPHIL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.661440 · Updated: 2026-03-14T23:02:54.359020