Label: SUNMARK 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 July 29, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (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
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

    Stop use and ask a doctor if you have:

    • rectal bleeding
    • no bowel movement after use

    These symptoms may indicate a serious condition.

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

    Keep out of reach of children.

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

  • Directions

    Single daily dosage

    Do not use more unless directed by a doctor. See Warnings.

    Adults and children 12 years old and over1 bottle
    Children 2 to under 12 years old1/2 bottle once daily
    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 1-5 minutes
    • carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.
  • Inactive ingredients

    none

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • SPL UNCLASSIFIED SECTION

    Distributed By Strategic Sourcing Services LLC
    6555 State Highway 161, Irwing, TX 75039

  • PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

    sunmark®

    COMPARE TO FLEET®
    MINERAL OIL ENEMA
    ACTIVE INGREDIENT*

    NDC 49348-185-20

    complete
    ready-to-use

    enema

    Mineral Oil

    Sodium free lubricant
    laxative for relief of
    occasional constipation

    Comfortable,
    lubricated tip

    Works in minutes

    NOT MADE WITH
    NATURAL RUBBER
    LATEX

    4.5 FL OZ
    (133 ml)

    Principal Display Panel - 133 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK MINERAL OIL  LAXATIVE
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-185
    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:49348-185-201 in 1 CARTON11/13/2002
    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 FINALpart33411/13/2002
    Labeler - McKesson (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(49348-185)
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