Label: GLYCERIN ADULT- glycerin suppository
Contains inactivated NDC Code(s)
NDC Code(s): 54868-2923-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0132-0079
- 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.
Updated December 14, 2011
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- Active Ingredient (in each suppository)
- Ask a doctor before using any laxative if you have
- Stop use and consult a doctor if you have
- Keep out of reach of children
Single daily dosage
adults and children 6 years and over
1 suppository, or as directed by a doctor
children 2 to under 6 years
use Pedia-Lax Glycerin Suppositories
children under 2 years
ask a doctor
Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2923(NDC:0132-0079) 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 EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-2923-0 12 in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/09/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel