FDA.reportPublic FDA data

Premier Value Fiber Capsules

Manufacturer
Chain Drug Consortium, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:25

Label at a glance#

ProductPremier Value Fiber
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 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times a day. Generally produces effect in 12-72 hours ▪ children 12 years and under: ask a d...

Storage and handling

▪ each capsule contains potassium 5 mg ▪ capsules are sealed using a band around the middle ▪ store at room temperature tightly closed to protect from humidity ▪ contains a 100% natural, therapeutic fiber TAMPER EVIDENT: DO NOT USE IF PRINTED 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

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times a day. 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 tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber

TAMPER EVIDENT: DO NOT USE IF PRINTED 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

NDC 68016-649-00

COMPARE TO THE ACTIVE INGREDIENT IN METAMUCIL® CAPSULES 3 in 1 MULTIHEALTH FIBER!™*

Premier Value®

Fiber Capsules

100% NATURAL PSYLLIUM HUSK
FIBER LAXATIVE/DIETARY SUPPLEMENT

  • Helps maintain healthy blood sugar levels as part of your diet**
  • Helps lower cholesterol to promote heart health
  • Promotes digestive health**
  • Gluten free

160 CAPSULES

Distributed by

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd.,

Suite 101, Boca Raton FL 33431

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil Capsules 3 in 1 MultiHealth Fiber!™*

Premier Value Fiber Capsules
Premier Value Fiber Capsules

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-649-002021-10-11C16284748780-1ba0f9c33-13d7-a910-e053-dadaa90a0b85Premier Value Fiber Capsules
68016-649-002021-01-29C16284748780-1ba0f9c33-13d7-a910-e053-dadaa90a0b85Premier Value Fiber Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-649-00Premier Value Fiber100 in 1 BOTTLECAPSULE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-649PREMIER VALUE FIBER (PSYLLIUM HUSK) CAPSULE [CHAIN DRUG CONSORTIUM, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_c507fe4a-1f8e-4780-a2f5-9da6e5922bef.zip

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
68016-64968016-649-00

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
Psyllium Husk0SHO53407GACTIB
CARAMELT9D99G2B1RIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
POLYSORBATE 806OZP39ZG8HIACT

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
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
ndc (package): 68016-649-00
ndc (product): 68016-649
ndc11 (package): 68016064900
spl id: a608d1db-5229-4bc6-ae02-e06e45c69c1e
spl set id: c507fe4a-1f8e-4780-a2f5-9da6e5922bef

Reported adverse events (FAERS/openFDA)#

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