Label: STRATUSCARE ADULT GLYCERIN- glycerin suppository
- NDC Code(s): 58980-410-12, 58980-410-25, 58980-410-50
- Packager: Stratus Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 2, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per suppository)
- Purpose
- Use
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Warnings
For rectal use only.
May cause rectal discomfort or burning sensation.
Ask a doctor before use if you have:
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks.
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Directions
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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
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Adults and children 6 years and over:
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 Suppository Jar Label
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INGREDIENTS AND APPEARANCE
STRATUSCARE ADULT GLYCERIN
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-410 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 2 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SODIUM STEARATE (UNII: QU7E2XA9TG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-410-12 12 in 1 JAR; Type 0: Not a Combination Product 05/30/2014 2 NDC:58980-410-25 25 in 1 JAR; Type 0: Not a Combination Product 05/30/2014 3 NDC:58980-410-50 50 in 1 JAR; Type 0: Not a Combination Product 05/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/30/2014 Labeler - Stratus Pharmaceuticals (789001641) Establishment Name Address ID/FEI Business Operations Tarmac Products 059890491 MANUFACTURE(58980-410)