PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.]

PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.]
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NDC 53329-013-11
Set ID 96d4cad5-0602-4c31-94ed-3117b4fd4a94
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient (in each 118 mL delivered dose)

    Mineral oil 100% w/v

  • Purpose

    Lubricant laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces bowel movement in 2 to 15 minutes
  • Warnings

    For rectal use only

    Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

    Do not use

    • on children under 13 years of age
    • on pregnant women
    • on persons with difficulty swallowing
    • on bedridden patients
    • if you are presently taking a stool softener laxative
    • or take with meals

    Ask a doctor before use if you

    • have already used a laxative for more than 3 days
    • have abdominal pain, nausea or vomiting
    • have 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
    • you have no bowel movement within 30 minutes of enema use

    As with any drug, if you are nursing a baby,

    seek the advice of a health professional before using this product.

    Keep out of reach of children.

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

  • Directions (or as directed by a doctor)

    Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours)

    adults & children

    13 years and over

    1 bottle

    children under 13 years of age

    DO NOT USE

    Caution:

    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. This product generally produces a bowel movement in 2 to 15 minutes.
    • Do not retain enema solution in body for longer than 15 minutes.
  • Other Information

    • store at room temperature 15-30°C (59-86°F)
    • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
  • Inactive ingredient

    none

  • Questions or comments?

    1-866-323-0107

  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093

    Made in USA

    www.medline.com

    1-800-MEDLINE

    REF: CUR095010

    RD21NPX

  • Package Label

    53329-013

  • INGREDIENTS AND APPEARANCE
    PURE AND GENTLE 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-013
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-013-111 in 1 BOX04/09/2014
    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 finalpart33404/09/2014
    Labeler - Medline Industries, LP (025460908)

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