[C.B. Fleet Company, Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph not final|
NOTE: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.
- for relief of fecal impaction
- for relief of occasional constipation
- for removal of residue after barium administration
Single daily dose
|adults and children 12 years and over||1 bottle
|children 2 to under 12 years||one-half bottle
|children under 2 years||DO NOT USE
- sodium free
- this product generally produces a bowel movement in 2-15 minutes
- carton sealed for safety. If seal with Fleet emblem on top or bottom flap is missing, do not use
- consult Physicians' Desk Reference for complete professional labeling
- 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
- rectal bleeding
- no bowel movement after use
These symptoms may indicate a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
mineral oil enema
|Labeler - C.B. Fleet Company, Inc. (003119054)|
|C.B. Fleet Company, Inc.||003119054||manufacture(0132-0301)|
Document Id: cc07b787-9d74-43c7-9efd-7877dd0efe41
Set id: 2528cb5e-437e-41f0-9c34-e9ce57404d8b
Effective Time: 20130213
C.B. Fleet Company, Inc.