FDA.reportPublic FDA data

Dr. Fibra

Manufacturer
Pharmadel LLC
Effective date
2024-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:46

Label at a glance#

ProductDr. Fibra
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Indications and uses

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.

Dosage and administration

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. adults and children 12 years of age and older 1 packet up to 3 times a day children 6 to under 12 years of age 1/2 packet up to 3 times a day children under 6 years of age consult a doctor First time users: Start with the 1 packet pe...

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each packet)Purpose
Psyllium seed husk 3.4 g....................Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.

Warnings

WARNINGS SECTION

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 allergic reactions in people, sensitive to inhaled or ingested psyllium.

Do not use

OTC - DO NOT USE SECTION

  • if allergic to any ingredient in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • a sodium restricted diet

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • take this product 2 hours before or after other drugs

Stop use and ask a doctor if

OTC - STOP USE SECTION

• constipation lasts more than 7 days
• rectal bleeding occurs
• you fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

adults and children 12 years of age and older

1 packet up to 3 times a day

children 6 to under 12 years of age

1/2 packet up to 3 times a day

children under 6 years of age

consult a doctor

First time users: Start with the 1 packet per day, gradually increase to 3 times a day, as necessary. As your body adjust to increased fiber intake, you may experience changes in bowel habits and/or minor bloating.

Other information

OTHER SAFETY INFORMATION

  • each packet contains: potassium 36 mg; sodium 178 mg
  • store below 86°F (30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C yellow #6, flavors, povidone k-30, sodium bicarbonate, sucralose

Questions?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC.

New Castle, DE 19720

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Fibra PDP BOXDr Fibra PDP BOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN2
824586psyllium 3400 MG Powder for Oral SuspensionSCD2
824586psyllium 3.4 GM Powder for Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-418-10Dr. Fibra10 in 1 BOXPOWDER102
55758-418-10Dr. Fibra1 in 1 PACKETPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-418DR. FIBRA (PSYLLIUM HUSK) POWDER [PHARMADEL LLC]2Current NDC, 2 package rows20240724_1a6151c9-e1c4-f0c1-e063-6394a90aad24.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
55758-41855758-418-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POVIDONE K30U725QWY32XIACT
PSYLLIUM HUSK0SHO53407GACTIB
SUCRALOSE96K6UQ3ZD4IACT

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
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
ndc (package): 55758-418-10
ndc (product): 55758-418
ndc11 (package): 55758041810
spl id: 1ddc7cb3-05e6-6453-e063-6294a90a620a
spl set id: 1a6151c9-e1c4-f0c1-e063-6394a90aad24

Reported adverse events (FAERS/openFDA)#

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