Label: GLYCERIN- glycerin suppository
- NDC Code(s): 63868-282-25
- Packager: Chain Drug Marketing Association 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 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 or a 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 within 1 hour of using this product
These symptoms may indicate a serious condition.
- Other information
- Inactive ingredients
Pediatric Glycerin Suppositories, 25 count
The product package shown below represents a sample of that currently in use. Additional packaging may also be available.
PediatricGlycerin Suppositories, 25 count
Distributed by C.D.M.A. Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-282 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:63868-282-25 25 in 1 JAR; Type 0: Not a Combination Product 03/20/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/20/2012 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - DSC Laboratories Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories Inc. 097807374 manufacture(63868-282)