QUALITY CHOICE- psyllium husk powder, for suspension

Quality Choice by

Drug Labeling and Warnings

Quality Choice by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• ▪ 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

silica, sucrose.

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®

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

www.qualitychoice.com

Questions: 248-449-9300

INGREDIENTS AND APPEARANCE

QUALITY CHOICE 
psyllium husk powder, for suspension

Product 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)