Label: STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC- glycerin suppository
- NDC Code(s): 58980-409-12, 58980-409-25
- Packager: Stratus Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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
- Warnings
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Directions
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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.
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Children 2 to under 6 years of age:
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 Suppository Jar Label
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INGREDIENTS AND APPEARANCE
STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-409 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 1 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:58980-409-12 12 in 1 JAR; Type 0: Not a Combination Product 06/01/2014 2 NDC:58980-409-25 25 in 1 JAR; Type 0: Not a Combination Product 06/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 06/01/2014 Labeler - Stratus Pharmaceuticals (789001641) Establishment Name Address ID/FEI Business Operations Tarmac Products 059890491 MANUFACTURE(58980-409)