Label: INFANT GLYCERIN LAXATIVE- glycerin suppository
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6186-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-2666
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 28, 2010
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
For rectal use only. May cause rectal discomfort or a burning sensation.
Do not use
- more than one per day
- for a period of longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
- if seal under product lid is damaged, missing or broken.
Ask a doctor
- before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
- if you are pregnant or nursing a baby
Stop use and ask a doctor
- if you have rectal bleeding or fail to have a bowel movement after using a
laxative. This may indicate a serious condition.
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL
For relief of
12 Infant Suppositories
Compare to Fleet® Glycerin Suppositories*
*This product is not manufactured or distributed by C.B.Fleet co., owner of
the registered trademark Fleet®.
31778 Enterprise Drive
Livonia, MI 48150 USA
Reorder No. 233874
M-54 Rev 6/08
DO NOT USE IF PRINTED
INNER SEAL IS BROKEN
Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
INGREDIENTS AND APPEARANCE
INFANT GLYCERIN LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6186(NDC:0904-2666) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.3 g Inactive Ingredients Ingredient Name Strength SODIUM STEARATE (UNII: QU7E2XA9TG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6186-0 12 in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part334 10/27/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel