Label: ADULT GLYCERIN LAXATIVE - glycerin suppository
- NDC Code(s): 49348-159-05, 49348-159-09
- Packager: McKesson
- 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 February 22, 2010
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- ACTIVE INGREDIENT
Glycerin, USP 80.7%Close
For relief of occasional constipationClose
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 vominting 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 persist 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.
- Adults and children 6 years of age and older: carefully insert one suppository well into the rectum
- Do not use more than once per day
- Generally produces a bowel movement in 15 minutes to 1 hour
- Children under 6 years of age: ask a doctor.
- OTHER INFORMATION
- Store container tightly closed
- Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
- INACTIVE INGREDIENTS
sodium stearate, purified water Close
- PACKAGE LABEL - 25 count
COMPARE TO FLEET® ACTIVE INGREDIENT*
For fast, gentle relief of
Another Quality Product
Distributed by McKesson
One Post Street, San
Francisco, CA 94104
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USE ONLY IF PRINTED INNER SEAL IS NOT BROKEN OR MISSING
*This product is not manufactured or distributed by C.B. Fleet Co., owner of the registered trademark Fleet®.
- INGREDIENTS AND APPEARANCE
ADULT GLYCERIN LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-159 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin 1.614 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:49348-159-05 25 in 1 JAR 2 NDC:49348-159-09 50 in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part334 08/03/2005 Labeler - McKesson (177667227)