Original texture Orange flavor

Manufacturer
Sunmark
Effective date
2012-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:03

Label at a glance#

ProductOriginal texture Orange flavor
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

effective in treating occasional constipation and restoring regularity

Dosage and administration

take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take 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. if you are tak...

Storage and handling

each tablespoon contains: potassium 30 mg and sodium 5 mg store at (20 o -25 o C) 68 o -77 o F

Label contents#

Full prescribing information#

Active ingredient (per each rounded tablespoon=11 g)

OTC - ACTIVE INGREDIENT SECTION

Psyllium husk 3.4 g

Purpose

OTC - PURPOSE SECTION

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

  • effective in treating occasional constipation and restoring regularity

Warnings

WARNINGS SECTION

Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits persisting for 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the maximum recommended daily dosage in a 24-hour period
  • you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • constipation lasts more than 7 days
  • rectal bleeding occurs
These could 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take at the first sign of irregularity up to 3 times a day
  • put one dose into an empty glass
  • fill glass with 8oz of water or favorite beverage
  • stir briskly and drink promptly
  • if mixture thickens add more water and stir
  • take 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.
  • 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 dose per day; gradually increase to 3 doses per day as necessary

adults and children 12 years and over
1 rounded tablespoon                         
6 to under 12 years
1/2 tablespoon
under 6 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablespoon contains: potassium 30 mg and sodium 5 mg
  • store at (20o-25oC) 68o-77oF

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD and C yellow 6, natural and artificial flavor, silicon dioxide, sucrose

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR BROKEN

Fiber Supplement information

SPL UNCLASSIFIED SECTION

Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts

Directions Adults 12 years and older: 1 rounded TABLESPOON (tbsp) in 8 oz  of liquid 3 times daily.

Children under 12 years:  Consult a doctor.

NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take  if you havbe difficulty swallowing.  See choking warning.

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunmark

compare to the active ingredient in Metamucil®

fiber Original Texture

Bulk-forming laxative

Dietary fiber supplement

100% Natural Psyllium Seed Husk Fiber

Orange Flavor

Naturally and Artificially Flavored

48 Tablespoon doses

Net wt 19 oz  (1.1 LBS 3 OZ) (538 g)

Fill controlled by weight, not volumeoriginal texture orange flavororiginal texture orange flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN1
824586psyllium 3400 MG Powder for Oral SuspensionSCD1
824586psyllium 3.4 GM Powder for Oral SuspensionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010939407337GTIN-13: 0010939407337
EAN-13: 0010939407337
GTIN-12: 010939407337
UPC-A: 010939407337
GTIN storage (14 digits): 00010939407337
SM402.jpg

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
49348-047-652020-01-31C16284748780-19d75b9d0-03a3-f424-e053-dadaa90a57ceSunmark Fiber Original Texture Orange Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-047-65Original texture Orange flavor538 g in 1 CANISTERPOWDER, FOR SUSPENSION5381

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-047ORIGINAL TEXTURE ORANGE FLAVOR (PSYLLIUM HUSK) POWDER, FOR SUSPENSION [SUNMARK]1Legacy NDC, 1 package rows20120918_326294b7-541b-4616-be17-ff4f5af5485f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-047-65GM - Gram49348-047e992f92e-c6b1-4c37-b8ff-3a90a22f60b912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PSYLLIUM HUSKACTIVE INGREDIENT0SHO53407G1
PSYLLIUM HUSKACTIVE MOIETY0SHO53407G1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SUCROSEINACTIVE INGREDIENTC151H8M5541

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
49348-04749348-047-65

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii candidate
34 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
61 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
61 equally ranked IID candidates

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
9bde93d4-81fc-4461-b77e-5f75d49dd0b6326294b7-541b-4616-be17-ff4f5af5485f2012-09-18WarningsExact identifier
spl id: 9bde93d4-81fc-4461-b77e-5f75d49dd0b6
spl set id: 326294b7-541b-4616-be17-ff4f5af5485f

Reported adverse events (FAERS/openFDA)#

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