FIBER LAXATIVE CAPLETS- calcium polycarbophil tablet

FIBER LAXATIVE CAPLETS by

Drug Labeling and Warnings

FIBER LAXATIVE CAPLETS by is a Otc medication manufactured, distributed, or labeled by Gendose Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CAPLET)

CALCIUM POLYCARBOPHIL 625 MG

(EQUIVALENT TO 500 MG POLYCARBOPHIL)

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE CAPLETS 
calcium polycarbophil tablet

Product 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 Drug	M007	09/02/2022

Labeler - Gendose Pharmaceuticals, LLC (080257510)