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  5. Label Information: Fiber Caps

FDA Label for Fiber Caps

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Fiber Caps Product Label

The following document was submitted to the FDA by the labeler of this product Guardian Drug Company. 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


Uses



relieves:

  • constipation
  • helps restore and maintain regularity
  • promotes normal function of the bowel
  • this product generally produces bowel movement in 12 to 72 hours

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 immediately.


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 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
  • rectal bleeding occurs


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.
    • 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 a day
      children under 12 years
      		ask a doctor


Other Information



  • each caplet contains: calcium 135 mg
  • do not use if printed seal under cap is torn or missing
  • 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



Compare to the active ingredient in FIBERCON

NDC 53041-147-27

Stimulant Free

Fiber-Caps

Fiber Laxative

Calcium polycarbophil 625 mg

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