Label: STRATUSCARE ADULT GLYCERIN- glycerin suppository

  • NDC Code(s): 58980-410-12, 58980-410-25, 58980-410-50
  • 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 November 2, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per suppository)

    Glycerin, USP 2 g

  • 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 you have:

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

    Stop use and ask a doctor:

    • if you have rectal bleeding or fail 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

    • If pregnant or breastfeeding, ask a doctor before use.

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

  • Directions

    • Adults and children 6 years and over:
      • Carefully insert one suppository well into 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 6 years old: do not use
  • Other information

    • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
    • Keep container tightly closed
  • 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 - 50 Suppository Jar Label

    NDC 58980-410-50

    STRATUSCARE

    ADULT

    Glycerin
    Suppositories
    Laxative

    Distributed by:
    STRATUS
    PHARMACEUTICALS INC

    DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

    50 SUPPOSITORIES

    Principal Display Panel - 50 Suppository Jar Label
  • INGREDIENTS AND APPEARANCE
    STRATUSCARE ADULT GLYCERIN 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-410
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-410-1212 in 1 JAR; Type 0: Not a Combination Product05/30/2014
    2NDC:58980-410-2525 in 1 JAR; Type 0: Not a Combination Product05/30/2014
    3NDC:58980-410-5050 in 1 JAR; Type 0: Not a Combination Product05/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/30/2014
    Labeler - Stratus Pharmaceuticals (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tarmac Products059890491MANUFACTURE(58980-410)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!