Active Ingredient (In Each Caplet)
CALCIUM POLYCARBOPHIL 625 MG
(EQUIVALENT TO 500 MG POLYCARBOPHIL)
Fiber Laxative Caplets Tablet
FDA Label NDC 77333-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Fiber Laxative Caplets (NDC 77333-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
BULK-FORMING LAXATIVE
Uses
- RELIEVES OCCASIONAL CONSTIPATION TO HELP RESTORE AND MAINTAIN REGULARITY
- THIS PRODUCT GENERALLY PRODUCES BOWEL MOVEMENT IN 12 TO 72 HOURS
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
- 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.
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
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.
Otc - Keep Out Of Reach Of Children
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.
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
* Please review the disclaimer below.
