Mineral Oil
FDA Label NDC 61767-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Mineral Oil (NDC 61767-001). 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 otc - active ingredient, purpose, warnings:, as a doctor before use if you have:, indications & usage, keep out of reach of children, other information:, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                            Purpose

Mineral Oil, 100%                    Lubricant Laxative            

Purpose

  • Gentle relief of occasional constipation

Warnings:

For rectal use only



As A Doctor Before Use If You Have:

  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks

    • If pregnant or breast feeding, ask a health professional before use.

Indications & Usage

  • If you have rectal bleeding or failure to have a bowel movement after use of a laxative because this amy indicate a serious condition
  • you need to use a laxative for more than one week

Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other Information:

  • Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
  • This product produces bowel movement in 2 to 15 minutes

Dosage & Administration

Single daily dose

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

Left-side position: Lie on left side with knee bent and arms at rest.

See image on box

Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.

See image on box

Administering Enema

  • With steady pressure, gently insert enema with tip pointing toward navel.

  • Squeeze bottle until recommended dose is expelled (it is not necessary to

    empty unit completely. Bottle contains more liquid than needed for effective

    use. A small amount of liquid will remain in bottle after squeezing).

  • Remove tip from rectum.

  • Stop using if tip is hard to insert. Forcing the tip into the rectum can

    cause injury (especially if you have hemorrhoids). If enema tip causes

    rectal bleeding or pain, get immediatemedical care.

  • Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).

  • If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor

    promptly if no liquid comes out of the rectum after 30 minutes because

    dehydration could occur.

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