Drug Facts
Active Ingredient (in each caplet)
Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
Calcium Polycarbophil Tablet
FDA Label NDC 70369-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Citragen Pharmaceuticals, Inc. for the product Calcium Polycarbophil (NDC 70369-006). 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 drug facts, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming Laxative
Uses
- relieves occasional constipation (irregularity)
- 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 cause 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
Ask A Doctor Before Use If You Have
- abdominal pain, nausea, or vomiting
- difficulty in swallowing
- a sudden change in bowel habits that persists over a period of 2 weeks
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.
When Using This Product
- do not use for more than 7 days unless directed by a doctor
Stop Use And Ask A Doctor If
- you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
- you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
- take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning
- adults and children over 12 years of age and over: take 2 caplets, 1 to 4 times per day. Do not take more than 8 caplets in one 24-hour period unless directed by a doctor.
- children under 12 years of age: ask a doctor
Other Information
- each caplet contains: calcium 140 mg; sodium 14 mg
- store in a dry place at 15° - 30°C (59° - 86°F)
- protect contents from moisture
Inactive Ingredients
Croscarmellose Sodium NF, Hydrogenated Vegetable Oil NF, Microcrystalline Cellulose NF and Sodium Chloride USP
Questions Or Comments?
Phone: +1-510-249-9066, 9AM-5PM PST, Mon-Fri; e-mail: [email protected]
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.
www.citragenpharma.com
Rev. 04/25 R-00
Package Label.Principal Display Panel
CitraGen Pharmaceuticals, Inc.
NDC: 70369-006-08
Calcium Polycarbophil Tablets 625 mg
Fiber Laxative Plus Calcium
Calcium Polycarbophil 625 mg
Bulk-Forming Laxative
Fiber Therapy for regularity
Compare to the active ingredient in FiberCon ®
This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®
120 Caplets
120 Count Label (Cg006 120s Fda Label)
CitraGen Pharmaceuticals, Inc.
NDC: 70369-006-10
Calcium Polycarbophil Tablets 625 mg
Fiber Laxative Plus Calcium
Calcium Polycarbophil 625 mg
Bulk-Forming Laxative
Fiber Therapy for regularity
Compare to the active ingredient in FiberCon ®
This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®
240 Caplets
240 Count Label (Cg006 240s Fda Label)
* Please review the disclaimer below.
