FDA.reportPublic FDA data

QC Natural Daily Fiber Sugar Free

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date
2021-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:10

Label at a glance#

ProductQC Natural Daily Fiber Sugar Free Orange Flavor
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

▪ for relief of occasional constipation (irregularity) ▪ Generally produces bowel movement in 12-72 hours

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 thickens, add more liquid and stir. Adults & Children 12 years & older: 1 rounded teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be ...

Storage and handling

▪ each teaspoon contains: potassium 35 mg; 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient: (in each teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Psyllium husk approximately 3.4 g

Purpose

OTC - PURPOSE SECTION

Bulk-forming Laxative

Uses:

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity)
  • Generally produces bowel movement in 12-72 hours

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

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 thickens, add more liquid and stir.

Adults & Children 12 years & older:

1 rounded teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

Children 6-11 yrs :

½ adult dose in 8 ounces of liquid, up to 3 times daily

Children under 6 yrs:

Consult a doctor

Bulk forming fibers like psyllium husk may affect how well other medicines work. If 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

SPL UNCLASSIFIED SECTION

Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other information:

STORAGE AND HANDLING SECTION

  • each teaspoon contains: potassium 35 mg; 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:

INACTIVE INGREDIENT SECTION

aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

*Compare to the Fiber Content in Metamucil® 4 in 1 MultiHealth Fiber! ™

Sugar Free not a low calorie food.

Fiber Therapy

100% NATURAL PSYLLIUM HUSK

Orange Smooth

Naturally and Artificially Flavored

MultiHealth Daily Fiber Supplement

Therapy for Regularity

  1. Helps you feel less hungry between meals**
  2. Helps maintain healthy blood sugar levels as part of your diet**
  3. Helps lower cholesterol to promote heart health†
  4. Promotes digestive health**
  5. Gluten free
  6. †See back for information about soluble fiber and heart disease.
  7. ‡Serving size varies. See DIRECTIONS on back panel for more information

114 Teaspoon Doses†

Net Wt. 23.3 oz. (1.4 LBS) 660 g

fill controlled by weight, not volume

**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 of Metamucil ®. 4 in 1 MultiHealth Fiber! ™.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

GLUTEN FREE (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product.

This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

100 % SASTISFACTION GUARANTEED

Distributed by: C.D.M.A, Inc. ©

43157 W 9 Mile Rd.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice Sugar Free Fiber Powder 48 teaspoons doses
Quality Choice Sugar Free Fiber Powder 48 teaspoons doses

114 Teaspoons doses

SPL UNCLASSIFIED SECTION

Qaulity Choice Siber Powder 114 teaspoons doses
Qaulity Choice Siber Powder 114 teaspoons doses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN2
824586psyllium 3400 MG Powder for Oral SuspensionSCD2
824586psyllium 3.4 GM Powder for Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-512-142023-01-30C16284748780-1f386c64a-48d9-0266-e053-dadaa90a7c1aQuality Choice 100% Natural Psyllium Husk Orange Flavor Sugar free
63868-512-482023-01-30C16284748780-1f386c64a-48d9-0266-e053-dadaa90a7c1aQuality Choice 100% Natural Psyllium Husk Orange Flavor Sugar free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-512-14QC Natural Daily Fiber Sugar FreeOrange Flavor660 g in 1 BOTTLE, PLASTICPOWDER6602
63868-512-48QC Natural Daily Fiber Sugar FreeOrange Flavor283 g in 1 BOTTLE, PLASTICPOWDER2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-512QC NATURAL DAILY FIBER SUGAR FREE ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 2 package rows20210122_183da451-cbf0-4920-b562-148cd4c5b967.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-512-14GM - Gram63868-5123f4e04be-6af1-4840-90a5-ee269e32c67a12022-10-06
63868-512-48GM - Gram63868-512cf895ed4-2bdc-47cc-91ec-2307a803deb412022-10-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-51263868-512-48, 63868-512-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB
ASPARTAMEZ0H242BBR1IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C Yellow No. 6H77VEI93A8IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
091704e0-bbbb-4ec9-8ac5-2d7771477634183da451-cbf0-4920-b562-148cd4c5b9672021-01-21WarningsExact identifier
spl id: 091704e0-bbbb-4ec9-8ac5-2d7771477634
spl set id: 183da451-cbf0-4920-b562-148cd4c5b967

Reported adverse events (FAERS/openFDA)#

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