Label: GLYCERIN- glycerin suppository
- NDC Code(s): 46122-222-63
- Packager: Amerisource Bergen/Good Neighbor Pharmacy
- 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 December 13, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each suppository)
For rectal use only
May cause rectal discomfort of burning sensation
Ask a Doctor before using any laxative if child has
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Stop use and consult a doctor if child has
- rectal bleeding
- no bowel movement after using this product
These symptoms may indicate a serious condition.
- Other information
- Inactive ingredients
Pediatriic Glycerin Suppositories, 25 count
The product shown represents a sample of that currently in use. Additional packaging may also be available.
Pediatric Glycerin Suppositories, 25ct.
Distributed by AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-222 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 HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-222-63 25 in 1 JAR; Type 0: Not a Combination Product 09/12/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/12/2013 Labeler - Amerisource Bergen/Good Neighbor Pharmacy (007914906) Registrant - DSC Laboratories Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories Inc. 097807374 manufacture(46122-222)