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| Product NDC Code | 77333-120 | ||||
|---|---|---|---|---|---|
| Drug Name | Fiber laxative caplets |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 308934 | ||||
| Application Number | M007 | ||||
| Labeler Name | Gendose Pharmaceuticals, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (IN EACH CAPLET) CALCIUM POLYCARBOPHIL 625 MG (EQUIVALENT TO 500 MG POLYCARBOPHIL)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS CALCIUM CARBONATE, CARAMEL COLOR, CROSPOVIDONE, HYPROMELLOSE, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SILICON DIOXIDE, SODIUM LAURYL SULFATE
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES RELIEVES OCCASIONAL CONSTIPATION TO HELP RESTORE AND MAINTAIN REGULARITY THIS PRODUCT GENERALLY PRODUCES BOWEL MOVEMENT IN 12 TO 72 HOURS
Purpose
Information about the drug product’s indications for use.PURPOSE BULK-FORMING LAXATIVE
Spl product data elements
Usually a list of ingredients in a drug product.FIBER LAXATIVE CAPLETS CALCIUM POLYCARBOPHIL HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE SILICON DIOXIDE CALCIUM CARBONATE MAGNESIUM STEARATE MALTODEXTRIN CROSPOVIDONE MICROCRYSTALLINE CELLULOSE CARAMEL CALCIUM POLYCARBOPHIL POLYCARBOPHIL mottled light-brown color with dark specs RP120 CAPLET
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_Fiber Laxative Caplets_50 caplets
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION EACH CAPLET CONTAINS: CALCIUM 125MG STORE AT ROOM TEMPERATURE PROTECT CONTENTS FROM MOISTURE
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API