The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Calcium Polycarbophil 625 Mg (NDC 69618-030). 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 other, active ingredient (in each caplet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Calcium polycarbophil 625 mg
(equivalent to polycarbophil 500 mg)
Bulk-Forming Laxative
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.
Do not use longer than one week
Ask a doctor before use if you have
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.
Stop use and ask a doctor if
These could be signs of a serious condition.
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
Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide
Questions or comments? call 516-341-0666,
8:30 am - 4:30 pm ET, Monday-Friday
NDC 69618-030-06
Calcium Polycarbophil 625mg
Bulk-Forming Laxative
90 Caplets
*Compare to Active Ingredient in FIBERCON®
* Please review the disclaimer below.
