Glycerin Suppository
FDA Label NDC 84415-041

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 84415-041). 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 using any laxative if child has, when using this product, stop use and consult a doctor if child has, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
    • 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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