FDA.reportPublic FDA data

Kroger Natural Fiber

Manufacturer
KROGER COMPANY
Effective date
2020-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:59

Label at a glance#

ProductKroger Natural Fiber Orange Flavor
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

• effective in treating occasional constipation and restoring 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 thickens, add more liquid and stir. Adults 12 years & older: 1 rounded TABLESPOON in 8 ounces of liquid at the first sign of irregularity. Can be taken up ...

Storage and handling

• each tablespoon contains: potassium 30 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 3.4 g

Purpose

OTC - PURPOSE SECTION

Fiber Laxative

Uses:

INDICATIONS & USAGE SECTION

  • effective in treating occasional constipation and restoring irregularity

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 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. Generally produces effect in 12-72 hours.

6-11 yrs :

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

under 6 yrs:

Consult a doctor

Laxative, including bulk fibers 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 dose per day; gradually increased to 3 doses per day as necessary.

Other information:

STORAGE AND HANDLING SECTION

  • each tablespoon contains: potassium 30 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

1-800-632-6900

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger®

QUALITY GUARANTEED

NDC 30142-512-72

COMPARE TO ACTIVE INGREDIENT OF Metamucil® MultiHealth Fiber*.

*See Back Panel

Smooth Texture

Natural Fiber

Orange Flavor

100% Natural Psyllium Husk

Fiber Laxative/Fiber Supplement

Naturally and Artificially Flavored

  • Helps Lower Cholesterol

See back for information about soluble fiber and heart disease.

72 TABLESPOON DOSES‡

NET WT 30.4 OZ (1 LB 14.4 OZ) 861 g

Fill controlled by weight, not volume

Our Pharmacists Recommend

K PAREVE

QUALITY GUARANTEED (if you are not completely satisfied with this product, return it for a refund or replacement.

Comments or Questions?

800-632-6900 www.kroger.com

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

*Metamucil is a registered trademark of Procter & Gamble, Cincinnati, OH 45202. Procter & Gamble is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.,

CINCINNATI, OHIO 45202

MADE IN U.S.A.

Kroger Smoothe Texture Natural Fiber
Kroger Smoothe Texture Natural Fiber

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN3
824586psyllium 3400 MG Powder for Oral SuspensionSCD3
824586psyllium 3.4 GM Powder for Oral SuspensionSY3

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
30142-512-722022-01-28C16284748780-1d6a99b39-cab9-a426-e053-dadaa90af4c2Kroger Smooth Texture Natural Fiber 72 tablespoon Doses

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-512-72Kroger Natural FiberOrange Flavor861 g in 1 BOTTLEPOWDER8613

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-512KROGER NATURAL FIBER ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [KROGER COMPANY]3Legacy NDC, 1 package rows20201020_0b86a903-6637-4033-a350-97d73e4f28ec.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
30142-51230142-512-72

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
ed742ab4-9fd4-455b-b731-51b1d60865a40b86a903-6637-4033-a350-97d73e4f28ec2020-10-16WarningsExact identifier
spl id: ed742ab4-9fd4-455b-b731-51b1d60865a4
spl set id: 0b86a903-6637-4033-a350-97d73e4f28ec

Reported adverse events (FAERS/openFDA)#

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