Label: GLYCERIN CHILDREN- glycerin suppository
- NDC Code(s): 57237-326-16, 57237-326-21, 57237-326-51, 57237-326-52
- Packager: Rising Pharma Holdings, Inc.
- 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 September 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GLYCERIN CHILDREN
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-326 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.2 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM STEARATE (UNII: QU7E2XA9TG) Product Characteristics Color white (clear) Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-326-21 2 in 1 CARTON 08/24/2023 1 NDC:57237-326-16 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57237-326-52 5 in 1 CARTON 08/24/2023 2 NDC:57237-326-51 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/24/2023 Labeler - Rising Pharma Holdings, Inc. (116880195) Establishment Name Address ID/FEI Business Operations Bliss GVS Pharma Limited 675630493 manufacture(57237-326) , analysis(57237-326) , pack(57237-326)
