Drug Fats
Active Ingredient (in each caplet)
Calcium polycarbophil 625 mg
equivalent to 500 mg polycarbophil
Premier Value Tablet, Film Coated
FDA Label NDC 68016-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value (NDC 68016-220). 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 fats, otc - purpose, uses, warnings, ask a doctor before use if you have, ask your 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
Otc - Purpose
PURPOSE
Bulk-forming laxative
Uses
▪ relieves occasional constipation to help restore and maintain regularity▪ this product generally produces bowel movement in 12 to 72 hours
Warnings
Choking Warning: 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▪ a sudden change in bowel habits that persists over a period of 2 weeks
Ask Your 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 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 tablets 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 laxative. 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 at 1-800-222-1222.
Directions
▪ Take each dose of this product 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.
Age | Recommended | Daily maximum |
adults & children 12 years of age and over | 2 caplets once a day | up to 4 times a day |
children under 12 years | consult a physician | |
Other Information
- each caplet contains: calcium 125 mg
- store at room temperature
- protect contents from moisture
Safety sealed: Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredient
calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, , polyethylene glycol, silicon dioxide, sodium lauryl sulfate.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 68016-220-25
Premier Value®
COMPARE TO THE ACTIVE INGREDIENTS FIBERCON® CAPLETS*
Fiber Caplets
Calcium Polycarbophil 625 mg
Bulk-Forming
Fiber Laxative
- Gentle Relief of Constipation
- Won’t Cause Gas or Bloating
- Effective as Fiber Powders
250 CAPLETS
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets
Premier Value Fiber Caplets 250 Counts (0339)
* Please review the disclaimer below.
