Stratuscare Adult Glycerin Suppository
FDA Label NDC 58980-410

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 Adult Glycerin (NDC 58980-410). 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 2 g

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 you have:

  • 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 you have rectal bleeding or fail 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 - Pregnancy Or Breast Feeding

  • If pregnant or breastfeeding, ask a doctor before use.

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

  • Adults and children 6 years and over:
    • Carefully insert one suppository well into 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 6 years old: do not use

Other Information

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

Inactive Ingredients

purified water, sodium stearate

Questions Or Comments?

1-800-442-7882

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NDC 58980-410-50

STRATUSCARE

ADULT

Glycerin
Suppositories
Laxative

Distributed by:
STRATUS
PHARMACEUTICALS INC

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

50 SUPPOSITORIES

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Principal Display Panel (50 Suppository Jar Label)

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