FDA.reportPublic FDA data

Discount Drug Mart

Manufacturer
DISCOUNT DRUG MART
Effective date
2021-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:04

Label at a glance#

ProductDiscount Drug Mart Orange Flavor
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

• for relief of occasional constipation (irregularly) • 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 oz of liquid at the first sign of irregularity. Can be ta...

Storage and handling

• each teaspoon contains: potassium 30 mg; sodium 5 mg • contains 100% natural, therapeutic fiber • store at room temperature. Keep the container tightly closed to protect from humidity

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 (irregularly)
  • 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 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

Laxatives, including bilk 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 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjust to increased fiber intake.

Other information:

STORAGE AND HANDLING SECTION

  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • contains 100% natural, therapeutic fiber
  • store at room temperature. Keep the container tightly closed to protect from humidity

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow 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 53943-513-72

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

SMOOTH TEXTURE

Fiber Therapy

POWDER

Fiber Laxative/Fiber Supplement

100% Natural Psyllium Husk

SUGAR FREE

  • 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†
  • Promotesdigestive health**

Orange Flavor

48 TABLESPOON DOSES

NET WT 20.3 oz 1.2 LBS (575 g)

Fill controlled by weight, not volume

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®.

SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.

Distributed By:

Drug Mart-Food Fair

211 Commerce Dr.

Medina, Ohio 44256

Smooth Texture Fiber Therapy
Smooth Texture Fiber Therapy

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-513-722023-01-30C16284748780-1f386c64a-2f4e-0266-e053-dadaa90a7c1aSmooth Texture Natural Fiber Powder Orange Flavor 48 Tablespoon Doses

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-513-72Discount Drug MartOrange Flavor575 g in 1 BOTTLEPOWDER5753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-513DISCOUNT DRUG MART ORANGE FLAVOR (PSYLLIUM HUSK NATURAL FIBER) POWDER [DISCOUNT DRUG MART]3Legacy NDC, 1 package rows20210824_fc8974f6-1e0e-4e2d-9d48-76522ec058ed.zip

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
53943-51353943-513-72

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
3a862ab3-b199-48a0-b57b-39d2c619450cfc8974f6-1e0e-4e2d-9d48-76522ec058ed2021-08-21WarningsExact identifier
spl id: 3a862ab3-b199-48a0-b57b-39d2c619450c
spl set id: fc8974f6-1e0e-4e2d-9d48-76522ec058ed

Reported adverse events (FAERS/openFDA)#

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