Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Fiber Laxative Plus Calcium (Calcium Polycarbophil 625 mg) Tablets
- Manufacturer
- CITRAGEN PHARMACEUTICALS, INC.
- Effective date
- 2025-04-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:08
Label at a glance#
ProductCalcium Polycarbophil
Active ingredientCALCIUM POLYCARBOPHIL
Label structure11 sections
Dosage and administration
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
Storage and handling
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
Contacts and useful links#
Websitewww.citragenpharma.com
www.citragenpharma.com
www.citragenpharma.comLabel contents#
Full prescribing information#
Drug Facts
Active Ingredient (in each caplet)
Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
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.
Keep out of reach of children.
OVERDOSAGE SECTION
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: info@citragenpharma.com
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.
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 ® 1
120 Caplets
1 This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 ® 2
240 Caplets
2 This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70369-006-08 | Calcium Polycarbophil | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 70369-006-10 | Calcium Polycarbophil | 240 in 1 BOTTLE | TABLET | 240 | 3 |
Products#
Every source-derived product name is available through these pages.
- Calcium Polycarbophil
- CROSCARMELLOSE SODIUM
- HYDROGENATED COTTONSEED OIL
- MICROCRYSTALLINE CELLULOSE
- SODIUM CHLORIDE
- POLYCARBOPHIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70369-006 | 70369-006-08, 70369-006-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYDROGENATED COTTONSEED OIL | Z82Y2C65EA | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| CALCIUM POLYCARBOPHIL | 8F049NKY49 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | CITRAGEN PHARMACEUTICALS, INC. | b23dd90f-ba5a-80fc-e053-2995a90a2286 | 2025-04-03 | Warnings | 70369-006-08 70369-006-10 70369-006 70369000610 70369000608 31db774c-a120-fb83-e063-6394a90a51ca b23dd90f-ba5a-80fc-e053-2995a90a2286 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.