Label: GLYCERIN- glycerin suppository suppository

  • NDC Code(s): 0904-7332-01, 0904-7332-17
  • Packager: MAJOR® PHARMACEUTICALS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 13, 2024

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  • Drug Facts

  • Active Ingredient

    Glycerin 1.2 g

  • Purpose

    Hyperosmotic Laxative

  • Uses

    For relief of occasional constipation. This product usually produces a bowel movement in 1/4 to 1 hour.

  • Warnings

    For rectal use only.

    Do not use

    laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

    Ask a doctor before using any laxative if child has

    • 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.

    When using this product

    rectal discomfort or burning sensation may occur

    Stop use and consult a doctor if child has

    • rectal bleeding
    • no bowel movement within 1 hour of using this product

    This may indicate a serious condition.

    Keep out of reach of children.

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

  • Directions

    Single Daily dosage: 1 suppository or as directed by a doctor

    Children 2 to 6 years:

    • tear wrapper prior to immediate use
    • remove the secondary wrapper before inserting into the rectum as follows:

          - hold suppository with pointed end up

          - carefully separate tabs with fingernail

          - gently pull apart by pulling tabs down on both sides

          - remove suppository from wrapper

          - insert one suppository well up into the rectum

    • Children under 2 years of age: ask a doctor
  • Other information

    • Only remove overwrap prior to immediate use
    • Keep from excessive heat
    • Do not use if overwrap is torn
  • Inactive ingredients

    polyethylene glycol 400, sodium stearate

  • Questions?

    (855) 879-4368

  • PRINCIPAL DISPLAY PANEL

    MAJOR®       NDC 0904-7332-17

    Children's Glycerin

    Suppositories

    1.2 g

    Laxative

    For fast, gentle relief of occasional constipation

    Unit Dose

    25 Individually Wrapped Child Size Suppositories

    PDP carton

  • PRINCIPAL DISPLAY PANEL

    MAJOR®       NDC 0904-7332-01

    Children's Glycerin

    Suppositories

    1.2 g

    Laxative

    For fast, gentle relief of occasional constipation

    DO NOT OPEN UNTIL IMMEDIATE USE

    Unit Dose

    1 Individually Wrapped Child Size Suppository

    PDP pouch

  • INGREDIENTS AND APPEARANCE
    GLYCERIN 
    glycerin suppository suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7332
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.2 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7332-1725 in 1 CARTON07/13/2024
    1NDC:0904-7332-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/13/2024
    Labeler - MAJOR® PHARMACEUTICALS (191427277)
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