Active Ingredient (In Each Teaspoon)
Psyllium husk approximately 3.4 g
Quality Choice
FDA Label NDC 63868-347
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Quality Choice (NDC 63868-347). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each teaspoon), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Questions: 248-449-9300
Qc(cdma) Sugar Free Natural Fiber Psyllium Husk (Gdc405)
* Please review the disclaimer below.
