FDA Label for Mineral Oil Lubricant Laxative

View Indications, Usage & Precautions

Mineral Oil Lubricant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each 118 mL delivered dose)

Mineral oil 100%


Purpose



Lubricant laxative


Uses



  • •for relief of occasional constipation

Warnings



For rectal use only


Ask A Doctor Before Use If You Have



  • •abdominal pain, nausea or vomiting
  • •notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use And Ask A Doctor If



  • •you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
  • •you need to use a laxative for more than one week

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



Single daily dose

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

1/2 bottle once daily

Discard unused portion

children under

2 years

do not use

How to use this enema:

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.

Positioning:

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.

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 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.

Other Information



  • •store at room temperature 20-25 deg C (68-77 deg F)
  • •this product generally produces bowel movement in 2-15 minutes

Inactive Ingredient



none


Questions Or Comments?



1-800-633-5463


Side And Principal Display Panel - Box



NDC 59779-996-11

CVS Pharmacy

 Compare to the active ingredient in Fleet Mineral Oil Enema

MINERAL OIL

ENEMA

LUBRICANT LAXATIVE

  •  Pre Mixed
  •  For relief of occasional constipation
  •  Lubricated tip
  • 4.5 FL OZ (133 ml)


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