Quality Choice

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date
2021-01-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:37:10

Label at a glance#

ProductQuality Choice
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

▪ for relief of occasional constipation (irregularity)

Dosage and administration

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...

Storage and handling

▪ 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

Label contents#

Full prescribing information#

Active ingredient (in each TEASPOON)

OTC - ACTIVE INGREDIENT SECTION

Psyllium husk approximately 3.4 g

Purpose

OTC - PURPOSE SECTION

Fiber therapy for regularity

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity)

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits persisting for 2 weeks
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Constipation lasts more than 7 days
  • Rectal bleeding occurs

These may be signs of a serious condition.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

silica, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Fiber Supplement Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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

QC(CDMA) Natural Fiber Powder 48 teaspoons doses
QC(CDMA) Natural Fiber Powder 48 teaspoons doses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN4
824586psyllium 3400 MG Powder for Oral SuspensionSCD4
824586psyllium 3.4 GM Powder for Oral SuspensionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-347-172023-01-30C16284748780-1f386c64a-465c-0266-e053-dadaa90a7c1aQuality Choice Natural Fiber Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-347-17Quality Choice368 g in 1 CANISTERPOWDER, FOR SUSPENSION3684

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-347QUALITY CHOICE (PSYLLIUM HUSK) POWDER, FOR SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC, 1 package rows20210122_118fc254-7964-418a-a359-558d853a91f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-347-17GM - Gram63868-347ad35f842-d1c8-4426-a79f-1b00ca5e84ef12019-06-19
63868-347-19GM - Gram63868-347404f5097-5343-4acb-8aa8-66367202280c12019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-34763868-347-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCROSEC151H8M554IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3eba1a32-6220-4c4c-86f5-b610240f5865118fc254-7964-418a-a359-558d853a91f52021-01-21WarningsExact identifier
spl id: 3eba1a32-6220-4c4c-86f5-b610240f5865
spl set id: 118fc254-7964-418a-a359-558d853a91f5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.