OneLAX

Manufacturer
Akron Pharma
Effective date
2023-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:15

Label at a glance#

ProductOneLAX
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

shake well before using follow dosing directions below or use as directed by a physician do not exceed recommended dose must be given in a 6 oz to 8 oz glass of milk or fruiit juice to prevent throat irritation take maximum dose daily until first bowel movement, dosage should then be reduced according to indivisual response

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool Softner Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do Not Use for more than one week unless directed by a doctor.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have stomach pain, nausea or vomiting
  • have sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of this product. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation

if pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask doctor before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Directions

OTC - WHEN USING SECTION

  • shake well before using
  • follow dosing directions below or use as directed by a physician
  • do not exceed recommended dose
  • must be given in a 6 oz to 8 oz glass of milk or fruiit juice to prevent throat irritation
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to indivisual response

DOSAGE & ADMINISTRATION SECTION

Age Dose
 Adults and children over 12 years of age and over 1 to 6 teaspoons (5 mL - 30 mL)
 Children under 12 years of age Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • wach teaspoonful (5 ml) contains: sodium 5 mg
  • store at room temperature 15o - 30oC (59o - 86oF)
  • protect from excessive heat
  • Pharmacist-preserve and dispense in a tight, light resistant container with a child resistant cap as defined in the USP
  • Temper -Evident: Do not use if foil over bottle opening is torn, broken, or missing

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, D&C red#33, Flavor vanilla, Glycerin, Methyl Paraben, Propylene glycol, Propyl paraben, Poloxamer 407, Purified water, Sodium benzoate, Sodium citrate, Sorbitol solution, Sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-877-225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0039-6ML - Milliliter71399-00391da92151-6f6d-49ba-8e9a-9e217910562e12023-09-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-003971399-0039-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
fcdbfa53-1565-4d9a-a100-841e018de4d6c692c99c-6fc8-42fb-bd8a-25ed4979d70b2025-01-05WarningsExact identifier
spl set id: c692c99c-6fc8-42fb-bd8a-25ed4979d70b

Reported adverse events (FAERS/openFDA)#

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