Label: QUALITY CHOICE- psyllium husk powder, for suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-347-17 - Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each TEASPOON)
- Purpose
- Uses
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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.
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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
- Inactive ingredients
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Fiber Supplement Information
Uses:
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- Daily fiber supplement. Each serving adds 3 grams of fiber to your diet.
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- 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†.
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Principal Display Panel
QUALITY CHOICE®
NDC# 63868-347-17
Compare to the active ingredient in Metamucil® MultiHealth Fiber*
Natural Fiber Powder
100% Natural Psyllium Husk
Daily Fiber Supplement | Therapy for Regularity
Helps Lower Cholesterol to Promote Heart Health**
Promotes Digestive Health†
Helps Maintain Healthy Blood Sugar Levels as Part of Your Diet**†
Gluten Free
Unflavored Original Coarse
**See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.
48 teaspoon doses
K PAREVE
Net Wt. 13 oz (368g)
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
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE
psyllium husk powder, for suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-347 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 5.8 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) Product Characteristics Color BROWN Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-347-17 368 g in 1 CANISTER; Type 0: Not a Combination Product 04/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/17/2019 Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
