Dynarex Laxative
FDA Label NDC 67777-404

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dynarex Laxative (NDC 67777-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, indications & usage, dosage & administration, keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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Dynarex Mineral Oil Laxative
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