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  5. Label Information: Dynarex Laxative

FDA Label for Dynarex Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. WARNINGS
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. KEEP OUT OF REACH OF CHILDREN
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRINCIPAL DISPLAY PANEL

Dynarex Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. 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.

Active Ingredient



Active Ingredient                         Purpose

Mineral oil                                    Intestinal lubricant


Purpose



Purpose

Relieves occassional constipation (irregularity).


Warnings



Warnings

Do not use:

  • If you have difficulty swallowing.
  • In children under 12 years of age.
  • If you are pregnant.
  • For a period longer than 1 week.
  • If you are bedridden or aged.

Indications & Usage



Indications & Usage

  • For relief of occassional constipation (irregularity).

    • When using this product 

    • Do not take with meals
    • Take only at bedtime

      • Ask a doctor before use if you have

      • Stomach reflux
      • Abdominal pain, nausea, or vomiting
      • Notice a sudden change in bowel habits that persist over a period of 2 weeks

        • Stop use and ask a doctor if

        • Rectal bleeding or failure to have a bowel movementafter use. These could be signs of a serious condition.

Dosage & Administration



Directions

  • Do not take with meals
  • Take only at bedtime
  • May be taken as a single daily dose or in divided doses.

    •                age

                          dose

    adults and children

    over 12 years

          1 to 3 tablespoons (15 to 45 ml)

          Maximum 3 tablespoons (45ml) in 24 hours

    children under

    12 years

          Consult a doctor


Keep Out Of Reach Of Children



Keep Out Of Reach Of Children

  • Keep this and all drugs out of the reach of children
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Information



Other information

  • Keep tightly closed
    • Protect from sunlight

Inactive Ingredients



Inactive ingredients: Butylated hydroxytoluene (BHT), Butylated hydroxyanisole (BHA)


Principal Display Panel



Dynarex Mineral Oil Laxative
4270 Min oil.jpg


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