Label: GOOD NEIGHBOR MINERAL OIL LAXATIVE- mineral oil enema

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 15, 2012

If you are a consumer or patient please visit this version.

  • 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

    If pregnant or breastfeeding, ask a health professional before use.

    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

    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.

    Remove protective shield illustration

    Positioning:

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

    Left Side position illustration

    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 illustration

    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.
  • 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

  • Side and Principal Display Panel - Box

    Good Neighbor Pharmacy Mineral Oil Enema box principal display panel

    NDC 46122-600-11

    Good Neighbor Pharmacy

    Ready-to-Use

    ENEMA

    MINERAL OIL

     
    Sodium free lubricant laxative for relief of occasional constipation
     
    Comfortable lubricated tip
     
    Works in minutes
     
    LATEX FREE

    4.5 FL OZ (133 ml)

  • Side and Back Panel - Box

    Good Neighbor Pharmacy Mineral Oil Enema box side and back
  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR MINERAL OIL LAXATIVE 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-600
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL118 mL  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-600-111 in 1 BOX
    1133 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/16/2012
    Labeler - Amerisource Bergen (007914906)