FDA Label for Gnp Fiber Therapy

View Indications, Usage & Precautions

Gnp Fiber Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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)



Methylcellulose 500 mg


Purpose



Bulk-forming laxative


Uses



  • helps restore and maintain regularity and relieves constipation (irregularity)
  • in the treatment of constipation associated with other bowel disorders when recommended by a doctor

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
  • a sudden change in bowel habits that persists over a period of 2 weeks
  • sensitivity to any of the ingredients

When Using This Product



  • do not exceed recommended maximum dose unless directed by a doctor
  • do not use laxative products for a period longer than one week unless directed by a doctor

Stop Use And Ask A Doctor If



  • rectal bleeding occurs
  • you fail to have a bowel movement after use

Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a poison control center right away.


Directions



This product generally produces effect in 12-72 hours

take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid

taking this product without enough liquid may cause choking, see choking warning

 AGEDOSE MAXIMUM DOSE 
 adults and children over 12 years    2 caplets up to 6 times daily
 children (6 to 12 years) 1 caplet up to 6 times daily
 children under 6 years ask a doctor          ask a doctor                  


Other Information



  • each caplet contains: sodium 10 mg
  • store at room temperature 15o-30oC (59o-86oF)
  • protect contents from moisture
  • keep tightly closed
  • tamper evident: Do not use if printed seal under cap is torn or missing

Inactive Ingredients



citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate


Principal Display Panel



Good Neighbor Pharmacy

compare to Citrucel caplets active ingredient

fiber therapy

Methylcellulose Fiber Laxativebulk-forming laxative

easy to take with you

gentle fiber for regularity

daily source of 100% soluble fiber

100 caplets


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