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  5. Label Information: Fiber Caplets

FDA Label for Fiber Caplets

View Indications, Usage & Precautions

Table of Contents

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

Fiber Caplets Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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 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 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



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


Directions



  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
  • continued use for 1 or 3 days is normally required to provide full benefit.

    •  adults and children 12 years and over                                                                  2 caplets, 1 to 4 times a day                                            
     Children under 12 years  ask a doctor


Other Information



  • each caplet contains: calcium 135mg
  • 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


How Supplied



Product: 71335-1075

NDC: 71335-1075-1 30 TABLET in a BOTTLE

NDC: 71335-1075-2 60 TABLET in a BOTTLE

NDC: 71335-1075-3 120 TABLET in a BOTTLE


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