Label: GLYCERIN suppository

  • Category: HUMAN OTC DRUG LABEL

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 20, 2009

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Glycerin, USP 80.7%

  • PURPOSE

    Laxative

  • USE

    For relief of occasional constipation

  • WARNINGS

    For rectal use only. May cause rectal discomfort or a burning sensation.

    Do not use

    • more than one per day
    • for a period of longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausea, or vominting are present unless directed by a doctor
    • if seal under product lid is damaged, missing or broken.

    Ask a doctor before use

    • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
    • if you are pregnant or nursing a baby







    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Adults and children 6 years of age and older: carefully insert one suppository well into the rectum
    • Do not use more than once per day
    • Generally produces a bowel movement in 15 minutes to 1 hour
    • Children under 6 years of age: ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    • Store container tightly closed
    • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
  • INACTIVE INGREDIENTS

    sodium stearate, water
  • QUESTIONS


  • PACKAGE LABEL

    TRIAD®

    NDC 50730-1092-1
    Cat. No. 10-10925

    GLYCERIN
    SUPPOSITORIES

    Laxative for fast, gentle relief of occasional constipation

    Adult sized

    Triad Group Inc.
    Brookfield, WI 53045 USA

    25
    suppositories


    label

  • INGREDIENTS AND APPEARANCE
    GLYCERIN 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1092
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin1.614 g
    Inactive Ingredients
    Ingredient NameStrength
    sodium stearate (UNII: QU7E2XA9TG)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1092-125 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33404/20/2003
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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

More Info on this Drug

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