ONELAX- docusate sodium liquid

OneLAX by

Drug Labeling and Warnings

OneLAX by is a Otc medication manufactured, distributed, or labeled by Akron Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active ingredient (in each 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softner Laxative

Uses

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

Warnings

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

Ask a doctor before use if you

• 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

• 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, 

ask doctor before use.

Keep out of reach of children

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

Directions

• 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

• 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

• 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:

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?

call toll-free 1-877-225-6999

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONELAX 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0039
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0039-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/04/2023

Labeler - Akron Pharma (067878881)