Label: FIBER LAXATIVE CAPLETS- calcium polycarbophil tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 77333-120-25, 77333-120-50 - Packager: Gendose Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
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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.
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIBER LAXATIVE CAPLETS
calcium polycarbophil tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77333-120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM CARBONATE (UNII: H0G9379FGK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CROSPOVIDONE (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARAMEL (UNII: T9D99G2B1R) Product Characteristics Color brown (mottled light-brown color with dark specs) Score no score Shape OVAL (CAPLET) Size 19mm Flavor Imprint Code RP120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77333-120-50 50 in 1 BOX 09/02/2022 1 NDC:77333-120-25 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/02/2022 Labeler - Gendose Pharmaceuticals, LLC (080257510)
