FDA Label for Quality Choice Fiber Therapy

View Indications, Usage & Precautions

Quality Choice 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)



Methylcellulose 500 mg


Purpose



Bulk-forming laxative


Use(S)



  • relieves occasional constipation to help restore and maintain regularity
  • generally produces a bowel movement in 12-72 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
  • a sudden change in bowel habits that persists over a period of 2 weeks

When Using This Product



  • do not use laxative products for a period longer than one week unless directed by a doctor.
  • do not use if you are on a low salt diet unless directed by a doctor.

Stop Use And Ask Doctor If



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

  •  AGE DOSEMAXIMUM DOSE 
     adults & children 12 years & over 2 caplets up to 6 times daily
     children 6 to 11 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 below 25oC (77oF)
  • protect contents from moisture
  • keep tightly closed

Inactive Ingredients



citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow no.6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulfate.


Principal Display Panel



NDC 63868-078-10
QC

QUALITY CHOICE

Fiber Therapy
Bulk Forming Laxative

Methylcellulose

Fiber Therapy for Regularity
Gentle & Gluten Free

100 Caplets



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