FDA Label for Fiber Therapy

View Indications, Usage & Precautions

Fiber Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Caplet)



Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil


Purpose



Bulk-forming laxative


Use(S)



  • relieves occasional constipation
  • this product 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 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 caplets in a 24 hour period unless directed by a  doctor

Stop Use And Ask 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



In case of over dose, get medical help or contact a Poison Control Center immediately.


Directions



  • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. 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 12 years and over2 caplets, 1 to 4 times a day 
     children under 12 years  ask a doctor








Other Information



  • each caplet contains: calcium 135 mg
  • store at room temperature
  • protect contents from moisture

Inactive Ingredients



calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.


Principal Display Panel



NDC 63868-169-90

QC

QUALITY CHOICE

*Compare to the Active Ingredient in Fibercon*

Fiber
Caplets

Calcium Polycarbophil 625 mg
Bulk-Forming Laxative for Relief of

Occasional Constipation


90 Caplets



* Please review the disclaimer below.