MedPath

Lidl Orange Smooth Fiber Powder

LIDL ORANGE SMOOTH 100% Natural Psyllium Husk Orange Flavor

Approved
Approval ID

c91ecf45-2d23-42e4-8639-840db4f902be

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

LIDL US, LLC

DUNS: 079389709

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Psyllium Husk

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71141-145
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Psyllium Husk
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (5)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PSYLLIUM HUSKActive
Quantity: 3.4 g in 12 g
Code: 0SHO53407G
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

PRINCIPAL DISPLAY PANEL

NDC71141-145-32

Made with Real Sugar

ORANGE SMOOTH

FIBER POWDER NATURALLY & ARTIFICIALLY FLAVORED

Compare to Psyllium in Metamucil ®4 in 1 MultiHealth Fiber*

Fiber POWDER

100% NATURAL PSYLLIUM HUSK

Bulk forming laxative/fiber supplement

  • Helps youfeel less hungrybetween meals**
  • Helps maintainhealthy blood sugar levelsas part of your diet******
  • Helpslower cholesterolto promote heart health†
  • Promotes**digestive health****
  • Gluten free

NET WT 30.4 OZ (861g)

fill controlled by weight, not volume

†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.

DO NOT USE IF PRINTED INNER SEAL UNDER CAP 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:

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-656-5151

www.lidl.com

LIDL ORANGE SMOOTH FIBER POWDER NATURAL Psyllium Husk

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/5/2018

Uses:

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/5/2018

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/5/2018

Active ingredient: (in each TABLESPOON)

Psyllium husk approximately 3.4 g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/5/2018

Purpose

Bulk-Forming Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 12/5/2018

Warnings:

Choking

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:

This product may cause an 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.**In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions:

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 oz 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 oz 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

Start with 1 serving per day; gradually increased to 3 doses per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/19/2025

Other information:

  • each tablespoon contains**:**potassium 35 mg; sodium 5 mg
  • contains a 100% natural, therapeutic fiber
  • store at room temperature tightly closed to protect from humidity

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/5/2018

Inactive ingredients

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

Questions or comments?

1-844-656-5151

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