FDA Label for Quality Choice

View Indications, Usage & Precautions

Quality Choice Product Label

The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 Teaspoon)



Psyllium husk approximately 3.4 g


Purpose



Fiber therapy for regularity


Uses



  • •for relief of occasional constipation (irregularity)

Warnings



Allergy alert: This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

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 persisting for 2 weeks

Stop Use And Ask A Doctor If



  • •Constipation lasts more than 7 days
  • •Rectal bleeding occurs
  • These may 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 at 1-800-222-1222.


Directions:



Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickness, add more liquid and stir.

Adults 12 years & older:

1 rounded TEASPOON in 8 oz of liquid at the signs of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

6-11 yrs:

½ adult dose in 8 oz of liquid, up to 3 times daily

Under 6 yrs:

Consult a doctor

Bulk-forming fibers like psyllium husk may affect how well other medicines work. If t=you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary


Other Information



  • each teaspoon contains: potassium 30 mg and sodium 5 mg
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • •Store at room temperature tightly closed to protect from humidity
  • •Do not use if printed inner seal is broken or missing
  • •Contains a 100% natural, therapeutic fiber

Inactive Ingredients



aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.


Questions Or Comments?



1-866-467-2748


Fiber Supplement Information



Uses:

  • •Daily fiber supplement. Each serving adds 3 grams of fiber to your diet.
  • •For lowering cholesterol to promote heart health. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One adults dose of this products has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as a part of a cholesterol lowering program.
  • Warnings Read entire label, including warnings in Drug Facts.

    Directions Adults 12 years and older: put 1 rounded TEASPOON in to an empty glass and mix with 8 oz of liquid up to 3 times daily for daily fiber supplement; 3 times daily to help maintain healthy blood sugar levels† and for cholesterol lowering to promote heart health.

    under 12 years: Consult a doctor.

    See mixing directions in Drug Facts.

    NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See choking warning.

    This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels†.


Principal Display Panel



QUALITY CHOICE®

Compare to the active ingredient in Metamucil® MultiHealth Fiber*

Sugar Free

Natural Fiber

Smooth Texture

100% Natural Psyllium Husk

Daily Fiber Supplement | Therapy for Regularity

Orange Smooth Fiber Powder

Helps Lower Cholesterol to Promote Heart Health**

Promotes Digestive Health†

Helps Maintain Healthy Blood Sugar Levels as Part of Your Diet**†

Gluten Free

**See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

Orange Flavor

114 teaspoon doses

K PAREVE

Net Wt. 23.3oz (660 g)

Fill controlled by weight, not volume

100% QC SATISFACTION GUARANTEED

†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

*This product is not manufactured or distributed by Procter & Gamble, the distributor, the distributor of Metamucil®.

Distributed by C.D.M.A., Inc. ©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300


* Please review the disclaimer below.