OneLAX Fiber Therapy

Manufacturer: Akron Pharma Inc.
Effective date: 2023-03-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:54:34

Label at a glance#

ProductOneLAX Fiber Therapy original coarse

Active ingredientPSYLLIUM HUSK

Label structure9 sections

Indications and uses

for relief of occasional constipation (irregularity) 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 teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be ...

Storage and handling

each teaspoon contains: potassium 35 mg; sodium 5 mg store at room temperature. Keep the container tightly closed to protect from humidity contains a 100% natural, therapeutic fiber

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-225-6999

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient: (in each teaspoon)

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 (irregularity)
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

Adults & children 12 years & older:	1 rounded teaspoon in 8 ounces 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 ounces 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. 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 increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other information

STORAGE AND HANDLING SECTION

each teaspoon contains: potassium 35 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, colloidal silicon dioxide, FD&C Yellow No.6, sucrose, orange flavor, sodium benzoate, sucralose.

Questions or comments ?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999.

Supplement Facts

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
824586	psyllium 3.4 GM Powder for Oral Suspension	PSN	1
824586	psyllium 3400 MG Powder for Oral Suspension	SCD	1
824586	psyllium 3.4 GM Powder for Oral Suspension	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71399-6585-3	2025-01-30	C162847	48780-1	2cef2736-ac61-d83d-e063-dadaa90ab31f	OneLAX Fiber Therapy 100% Natural Psyllium Husk Multihealth Dairy Fiber Supplement

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71399-6585-3	OneLAX Fiber Therapyoriginal coarse	368 g in 1 BOTTLE, PLASTIC	POWDER	368		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-6585	ONELAX FIBER THERAPY ORIGINAL COARSE (PSYLLIUM HUSK) POWDER [AKRON PHARMA INC.]	1	1 package rows	20230327_21b45187-34dc-4eb0-a167-2e843e08c35c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-6585-3	GM - Gram	71399-6585	5c7cb29f-63e1-45a3-941f-994a293ff9ab	1	2024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

OneLAX Fiber Therapy original coarse
Psyllium Husk
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
FD&C YELLOW NO. 6
Sucrose
SODIUM BENZOATE
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71399-6585	71399-6585-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PSYLLIUM HUSK	0SHO53407G	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
Sucrose	C151H8M554	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a32af723-fd8e-45fd-bcef-d582d922896c			21b45187-34dc-4eb0-a167-2e843e08c35c	2023-03-18	Warnings	Exact identifier spl id: a32af723-fd8e-45fd-bcef-d582d922896c spl set id: 21b45187-34dc-4eb0-a167-2e843e08c35c

Reported adverse events (FAERS/openFDA)#

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