Glycerin Suppository
FDA Label NDC 57237-326

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Glycerin (NDC 57237-326). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

Otc - Purpose

Purpose

Laxative

Warnings

Warnings

For rectal use only

Otc - Ask Doctor

Ask a doctor before use if the child has

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

Otc - Stop Use

Stop use and ask a doctor if child has

  • rectal bleeding
  • no bowel movement after using this product
  • These may indicate a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Inactive Ingredient

Inactive ingredients purified water, sodium stearate

Otc - Questions

Questions or Comments? Call 1-844-474-7464

Package Label.Principal Display Panel

NDC 57237-326-52 (5 blisters of 5 suppositories)

Children's Glycerin Suppositories 1.2 g

LAXATIVE

For fast, gentle relief of occasional constipation

For ages 2 to 5 years

Gly-child-supp-01 (Gly Child Supp 01)

Gly-child-supp-01 (Gly Child Supp 01)

Gly-child-supp-02 (Gly Child Supp 02)

Gly-child-supp-02 (Gly Child Supp 02)

NDC 57237-326-51 (5 suppositories in 1 blister pack)

Front Foil

Gly-child-supp-03 (Gly Child Supp 03)

Gly-child-supp-03 (Gly Child Supp 03)

Back Foil

Gly-child-supp-04 (Gly Child Supp 04)

Gly-child-supp-04 (Gly Child Supp 04)

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