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  5. Label Information: Onelax

FDA Label for Onelax

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENT (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. DOSAGE & ADMINISTRATION
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS:
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Onelax Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Factsactive 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


Package Label.Principal Display Panel



label - one lax docsod

label - one lax docsod


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