FDA.reportPublic FDA data

Quality Choice Fiber Capsules Psyllium Husk

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:16

Label at a glance#

ProductQuality Choice Fiber Laxative
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

effective in treating occasional constipation and restoring regularity

Dosage and administration

Take this product 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. Adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours children 12 years and under: Ask a doctor Laxa...

Storage and handling

each capsule contains: potassium 5 mg capsules are sealed using a band around the middle store at room temperature. Keep the container tightly closed to protect from humidity contains a 100% natural, therapeutic fiber do not use if printed inner seal under cap is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Psyllium husk approximately 0.52 g

Purpose

OTC - PURPOSE SECTION

Fiber laxative

Uses

INDICATIONS & USAGE SECTION

  • effective in treating occasional constipation and restoring regularity

Warnings

WARNINGS SECTION

Choking

SPL UNCLASSIFIED SECTION

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.

Allergy alert

SPL UNCLASSIFIED SECTION

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

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting

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

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

  • Take this product 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.
  • Adults 12 years and older:5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours
  • children 12 years and under:Ask a doctor
  • Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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.

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: potassium 5 mg
  • capsules are sealed using a band around the middle
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
  • do not use if printed inner seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel color, edible ink, gelatin, polysorbate 80

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 160 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice ®

NDC 63868-348-01

Compare to Metamucil ®Capsules ‡

Fiber Capsules

Psyllium Husk
Fiber Laxative/Dietary Supplement

Helps lower cholesterol to promote heart health†

Promotes digestive health**

Helps maintain healthy blood sugar levels as part of your diet* †

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

160 Capsules

Distributed by: C.D.M.A. Inc.,

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®3 in1 MultiHealth Fiber.

Quality Choice Fober Capsules 160 count
Quality Choice Fober Capsules 160 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581417psyllium 0.52 GM Oral CapsulePSN6
581417psyllium 520 MG Oral CapsuleSCD6
581417psyllium 0.52 GM Oral CapsuleSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130635515953727GTIN-13: 0635515953727
EAN-13: 0635515953727
GTIN-12: 635515953727
UPC-A: 635515953727
GTIN storage (14 digits): 00635515953727		119160PVLR_ol.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-348-01Quality ChoiceFiber Laxative160 in 1 BOTTLECAPSULE1606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-348-01EA - Each63868-348dd720205-3f80-41b7-8bfb-b7f287d85b5312019-06-19

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-34863868-348-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARAMELT9D99G2B1RIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
POLYSORBATE 806OZP39ZG8HIACT
PSYLLIUM HUSK0SHO53407GACTIB

Source Document#

Source XML

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
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
ndc (package): 63868-348-01
ndc (product): 63868-348
ndc11 (package): 63868034801
spl id: 4509829d-f1db-5358-e063-6294a90ac2a9
spl set id: 2ee637c4-c4c6-4a24-ae99-612205afd592

Reported adverse events (FAERS/openFDA)#

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