FDA Label for Calcium Polycarbophil 625 Mg
View Indications, Usage & Precautions
Calcium Polycarbophil 625 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark FIBERCON®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Active Ingredient (In Each Caplet)
Calcium polycarbophil 625 mg
(equivalent to polycarbophil 500 mg)
Purpose
Bulk-Forming Laxative
Uses
- relieves occasional constipation
- 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 esophagus and may cuase choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
Otc - Do Not Use
Do not use longer than one week
Otc - Ask Doctor
Ask a doctor before use if you have
- abdominal pain, nausea, or vomiting
- noticed a sudden change in bowel habits that lasts over two weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Otc - Stop Use
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after using this prodcut
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.
Drug Facts continued on back of label
Directions
- take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
- take dose up to 4 times daily
- do not take more than 8 caplets in 24 hours
- adults & children 12 years and over: 2 caplets
- children under 12 years: ask a doctor
Other Information
- each caplet contains: calcium 140 mg
- store at 15°-30°C (59°-86°F)
- do not refrigerate
- protect from humidity
Inactive Ingredient
Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide
Otc - Questions
Questions or comments? call 516-341-0666,
8:30 am - 4:30 pm ET, Monday-Friday
Package Label.Principal Display Panel
NDC 69618-030-06
Calcium Polycarbophil 625mg
Bulk-Forming Laxative
90 Caplets
*Compare to Active Ingredient in FIBERCON®
* Please review the disclaimer below.