Glycerin Suppository
FDA Label NDC 84415-039

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everpharm Llc for the product Glycerin (NDC 84415-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, when using this product, stop using this product and consult a doctor if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each suppository)

Glycerin, USP 2 g

Purpose

Hyperosmotic laxative

Uses

For relief of occasional constipation. This product usually produces a bowel movement in ¼ 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 Use If

  • you have 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 Using This Product And Consult A Doctor If You Have

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

    • This may indicate a serious condition.

If Pregnant Or Breastfeeding,

ask a doctor before use. 

Keep Out Of Reach Of Children.

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

Directions

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

 Adults and children 6 years and over

  • 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 2 to 6 years use Children's Glycerin Suppositories
    • Children under 2 years of age: ask a doctor
    • Suppository need not melt completely to produce laxative action   

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?

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