Stratuscare Glycerin Laxative Pediatric Suppository
FDA Label NDC 58980-409

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals for the product Stratuscare Glycerin Laxative Pediatric (NDC 58980-409). 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, active ingredient (per suppository), purpose, use, warnings, otc - ask doctor, otc - stop use, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

Active Ingredient (Per Suppository)

Glycerin, USP 1g

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.

Otc - Ask Doctor

Ask a doctor before use if your child has:

  • abdominal 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 your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.

Otc - Do Not Use

  • Do not use laxative products for longer than 1 week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

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

Directions

  • Children 2 to under 6 years of age:
    • Carefully insert one suppository well into child's 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 2 years old: Consult a doctor.

Other Information

  • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)

Inactive Ingredients

purified water, sodium stearate

Questions Or Comments?

1-800-442-7882

Principal Display Panel - 25 Suppository Jar Label

NDC 58980-409-25

STRATUSCARE

INFANTS
& CHILDREN

pediatrics
Glycerin
Suppositories
Laxative

Distributed by:
STRATUS
PHARMACEUTICALS INC

25 SUPPOSITORIES

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

Principal Display Panel (25 Suppository Jar Label)

Principal Display Panel (25 Suppository Jar Label)

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