Meijer
FDA Label NDC 41250-112

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer (NDC 41250-112). 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, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

(in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

  • for relief of occasional constipation

Warnings

For rectal use only

Ask 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

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Single daily dose

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

1/2 bottle once daily

Discard unused portion

children under

2 years

do not use

How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

Hand Positioning (9a0a757c B1cd 4a19 9e2b 41b2414a2070 01)

Hand Positioning (9a0a757c B1cd 4a19 9e2b 41b2414a2070 01)

 Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  • Do not force the enema tip into rectum as this can cause injury.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
  • Remove enema tip from rectum.
  • Retain enema in accordance with doctor's instructions.
  •  

    Positioning:

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

    Left Side Position (9a0a757c B1cd 4a19 9e2b 41b2414a2070 02)

    Left Side Position (9a0a757c B1cd 4a19 9e2b 41b2414a2070 02)

    Knee-chest position:

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

    Knee Chest Position (9a0a757c B1cd 4a19 9e2b 41b2414a2070 03)

    Knee Chest Position (9a0a757c B1cd 4a19 9e2b 41b2414a2070 03)

Other Information

  • store at room temperature 20-25 deg C (68-77 deg F)
  • this product generally produces bowel movement in 2-15 minutes

Inactive Ingredient

none

Questions Or Comments?

1-800-633-5463

Principal Display Panel

NDC 41250-112-11

Compare to Fleet® Mineral Oil Enema active ingredient*

Meijer

Ready-To-Use

Enema Mineral Oil

Sodium Free

Lubricant Laxative

For Relief of

Occasional Constipation

Latex Free

Protective Shield prevents contamination

Safety Seal for added protection

Comfortable, lubricated tip for insertion

One-way safety valve controls flow and prevents reflux

Easy, soft squeeze bottle

4.5 FL OZ (133ml)

Principal Display Panel With Drug Facts (9a0a757c B1cd 4a19 9e2b 41b2414a2070 04)

Principal Display Panel With Drug Facts (9a0a757c B1cd 4a19 9e2b 41b2414a2070 04)

* Please review the disclaimer below.