Label: GOOD NEIGHBOR PHARMACY 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 December 7, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 118 mL delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Use

    • 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
    • already used a laxative for more than 1 week

    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 us a laxative for more than one week

    If pregnant or breast-feeding, 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 over1 bottle once daily
    children 2 to under 12 years1/2 bottle once daily discard unused portion
    children under 2 yearsDO NOT USE
  • Other information

    • store at 15 to 30°C (59 to 86°F).
    • this product generally produces a bowel movement in 1 to 5 minutes
  • Inactive ingredients

    none

  • Questions or comments?

    Visit us at www.mygnp.com

  • SPL UNCLASSIFIED SECTION

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

    NDC 46122-363-28

    Compare to
    Fleet®Mineral Oil Enema
    active ingredient*

    GOOD
    NEIGHBOR
    PHARMACY®

    READY-TO-USE

    Enema

    Mineral Oil Laxative

    For relief of occasional
    constipation

    • Sodium free lubricant
      laxative for relief of
      occasional constipation
    • Comfortable,
      lubricated tip
    • Works in minutes

    Single
    Pack

    4.5 fl oz
    (133 ml)

    PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY MINERAL OIL LAXATIVE 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-363
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL118 g  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-363-281 in 1 CARTON03/15/2016
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33403/15/2016
    Labeler - AmerisourceBergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(46122-363)