Drug Facts
Active ingredient (in each caplet)
Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
Calcium Polycarbophil Tablet, Film Coated
FDA Label NDC 69842-846
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Calcium Polycarbophil (NDC 69842-846). 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
do not take more than 8 caplets in a 24-hour period 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 my cause choking. See choking warning.
dosage will vary according to diet, exercise, previous laxative use or severity of constipation
continued use for 1 to 3 days is normally required to provide full benefit
| adults and children over 12 years | 2 caplets, 1 to 4 times per day |
| children under 12 years | ask a doctor |
Other Information
each caplet contains: calcium 140 mg
do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
protect contents from moisture
Inactive Ingredient
Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid
Questions Or Comments?
1-800-231-4670
Other
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark FiberCon®
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
Package Label.Principal Display Panel
CVS
Health
Compare to the active ingredient in FiberCon®*
Fiber Laxative
Plus Calcium
Calcium Polycarbophil
Fiber Therapy for regularity
Gentle enough to use every day
Natural action of Fiber
250 Caplets
* Please review the disclaimer below.
