FDA.reportPublic FDA data

Premier Value Fiber Therapy

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:20

Label at a glance#

ProductPremier Value Fiber Therapy 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 tablespoon in 8 ounces of liquid at the first sign of irregularity. Can b...

Storage and handling

▪ each teaspoon contains: potassium 35 mg; sodium 5 mg ▪ store at room temperature. Keep the container tightly closed to protect from humidity ▪ contains a 100% natural, therapeutic fiber

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient: (in each tablespoon)

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 tablespoon 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.

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
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow No. 6, natural and artificial orange flavor, silica, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-513-72

COMPARE TO THE FIBER CONTENT IN METAMUCIL® 4 IN 1 MULTIHEALTH FIBER! ™*

Fiber Therapy

100% Natural Psyllium Husk

MultiHealth Daily Fiber Supplement Therapy for Regularity

Orange

Naturally and Artificially Flavored Powder

  • Helps you feel less hungry between meals**
  • Helps maintain healthy blood sugar levels as part of your diet**
  • Helps lower cholesterol to promote heart health†
  • Promotes digestive health**
  • Gluten free

72 TABLESPOON DOSES‡

NET WT 30.4 OZ (1.9 LBS) 861 g

fill controlled by weight, not volume

K PAREVE

‡Serving size varies See DIRECTIONS on back panel for more information

†See back for information about soluble fiber and heart disease.

**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.

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

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™.

GLUTEN FREE 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.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Premier Value Orange Flavor Psyllium Husk Powder
Premier Value Orange Flavor Psyllium Husk Powder

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN6
824586psyllium 3400 MG Powder for Oral SuspensionSCD6
824586psyllium 3.4 GM Powder for Oral SuspensionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-513-72Premier Value Fiber TherapyOrange Flavor861 g in 1 BOTTLEPOWDER8616

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-513PREMIER VALUE FIBER THERAPY ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_85651bd7-e959-4455-a5ed-bd0223ce0563.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-51368016-513-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C Yellow No. 6H77VEI93A8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCROSEC151H8M554IACT

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 Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
ndc (package): 68016-513-72
ndc (product): 68016-513
ndc11 (package): 68016051372
spl id: ffd14b1b-f6f2-42d7-8786-9ae0e72d7918
spl set id: 85651bd7-e959-4455-a5ed-bd0223ce0563

Reported adverse events (FAERS/openFDA)#

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