Your browser does not support JavaScript! MEDLINE ENEMA (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, INC.]
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MEDLINE ENEMA (mineral oil) enema
[Medline Industries, 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.
Drug Label Sections

Active ingredient (in each 118 mL delivered dose)

Mineral Oil USP

Purpose

Lubricant Laxative

Uses

  • 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.

 

Professional use:

  • for cleansing the bowel and removal of residue after barium enema administration.

Warnings

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.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

Illustration #1

Do not use more unless directed by a doctor. See Warnings.

adults & children 12 years and olderone bottle once daily
children 2 to under 12 years½ bottle once daily
children under 2 yearsdo not use

Positioning:

Left-side position: lie on left side with knee bent and arms at rest.

Illustration #2

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Illustration #3

Administering enema:

  • 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.

Other information

  • bottle, cap and shield are latex-free.
  • Consult Physicians’ Desk Reference® for complete professional labeling.

Principal Display Panel

Complete

Enema

Ready-to-Use

Mineral Oil

Comfortable, lubricated tip

Lubricant Laxative

Latex free product

Contents: 1 Each

Enema Carton

Enema Carton

MEDLINE ENEMA 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-008
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL118 mL  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-008-111 in 1 CARTON
1133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/06/2010
Labeler - Medline Industries, Inc. (025460908)

Revised: 1/2010
 
Medline Industries, Inc.

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