Active Ingredient (In Each Caplet)
Calcium Polycarbophil 625 mg
(equivalent to 500 mg polycarbophil)
Fiber Laxative Tablet, Film Coated
FDA Label NDC 57896-459
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Fiber Laxative (NDC 57896-459). 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 active ingredient (in each caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
- promotes regularity
- this product generally produces a 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.
Do not use • for more than 1 week unless directed by a doctor
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 a doctor or pharmacist before use if you are
• taking any other drug
• all laxatives may affect how other drugs work.
Stop use and ask a doctor if
• you have rectal bleeding
• you have no bowel movement within 3 days
• these could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed recommended dose
- take each dose with at least 8 ounces (a full glass) of fluid; taking this product without enough liquid may cause choking; see choking warning
- do not take this product within 2 hours before or after taking any other drug
| adults and children 12
years of age and older | Starting dose: 2 caplets once a day
Maximum dose: 2 caplets four times a day or as directed by a doctor |
| children under 12 years of age | consult a doctor |
Other Information
• each caplet contains: calcium 138 mg
• store at controlled room temperature, 68°F-77°F (20°C-25°C)
• protect contents from moisture
• for institutional use only
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients
caramel, cellulose, crospovidone, hypromellose,
magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium
lauryl sulfate, stearic acid. May also contain calcium carbonate, croscarmellose
sodium, maltodextrin, talc.
Package Label
GERICARE
NDC 57896-449-09
Fiber Laxative
Calcium Polycarbophil
• Relieves Constipation
• Promotes Regularity
90 Caplets
625 mg Each
Compare to active ingredient
in FiberCon®*
* Please review the disclaimer below.
