Label: MEDLINE ENEMA- mineral oil enema
- NDC Code(s): 53329-008-11
- Packager: Medline Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 5, 2010
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- Active ingredient (in each 118 mL delivered dose)
Mineral Oil USPClose
- for relief of fecal impaction or occasional constipation, without straining or irritating the mucosa of the bowel, by lubricating and softening the stool
- generally produces bowel movement in 2 to 15 minutes.
- for cleansing the bowel and removal of residue after barium enema administration.
Dosage warning: Using more than one enema in 24 hours can be harmful.
CAUTION: FOR RECTAL USE ONLY.
Ask a doctor before using any laxative if you:
- have nausea, vomiting, or abdominal pain
- have sudden change in bowel habits lasting more than 2 weeks
- have already used a laxative for more than 1 week
Ask a doctor or pharmacist before use if you
are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When using this product, do not use more than directed.
Serious side effects may occur from excess dosage.
Stop using this product and consult a doctor if you:
- have rectal bleeding
- have no bowel movement after the enema is given
These symptoms may indicate a serious condition.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.
Do not use more unless directed by a doctor. See Warnings.
adults & children 12 years and older one bottle once daily children 2 to under 12 years ½ bottle once daily children under 2 years do not use
Left-side position: lie on left side with knee bent and arms at rest.
Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
- With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
- Do not force the enema tip into the rectum as this can cause injury.
- Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
- Remove enema tip from rectum
- Retain enema in accordance with doctor’s instructions
Follow with a cleansing enema: To remove stools or other residue now softened or lubricated, it is suggested that you use a regular enema to cleanse the bowel.Close
- Other information
- bottle, cap and shield are latex-free.
- Consult Physicians’ Desk Reference® for complete professional labeling.
- Principal Display Panel
Comfortable, lubricated tip
Latex free product
Contents: 1 Each
- INGREDIENTS AND APPEARANCE
mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-008 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 118 mL in 118 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-008-11 1 in 1 CARTON 1 133 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/06/2010 Labeler - Medline Industries, Inc. (025460908)