Label: STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC- glycerin suppository

  • NDC Code(s): 58980-409-12, 58980-409-25
  • Packager: Stratus Pharmaceuticals
  • 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 October 14, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per suppository)

    Glycerin, USP 1g

  • Purpose

    Laxative

  • Use

    • For relief of occasional constipation (irregularity)
    • generally produces bowel movement in ¼ to 1 hour.
  • Warnings

    For rectal use only.

    May cause rectal discomfort or burning sensation.

    Ask a doctor before use if your child has:

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks.

    Stop use and ask a doctor:

    • if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.

    • Do not use laxative products for longer than 1 week unless directed by a doctor

    • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
  • Directions

    • Children 2 to under 6 years of age:
      • Carefully insert one suppository well into child's rectum
      • It need not melt completely to produce laxative action
      • Generally produces bowel movement in 15 minutes to 1 hour
      • Do not exceed one suppository daily unless directed by a doctor
    • Children under 2 years old: Consult a doctor.
  • Other information

    • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
  • Inactive ingredients

    purified water, sodium stearate

  • Questions or comments?

    1-800-442-7882

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc
    12379 SW 130th Street
    Miami, Florida 33186

  • PRINCIPAL DISPLAY PANEL - 25 Suppository Jar Label

    NDC 58980-409-25

    STRATUSCARE

    INFANTS
    & CHILDREN

    pediatrics
    Glycerin
    Suppositories
    Laxative

    Distributed by:
    STRATUS
    PHARMACEUTICALS INC

    25 SUPPOSITORIES

    DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

    Principal Display Panel - 25 Suppository Jar Label
  • INGREDIENTS AND APPEARANCE
    STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-409
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-409-1212 in 1 JAR; Type 0: Not a Combination Product06/01/2014
    2NDC:58980-409-2525 in 1 JAR; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33406/01/2014
    Labeler - Stratus Pharmaceuticals (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tarmac Products059890491MANUFACTURE(58980-409)