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Enema by H and P Industries, Inc. dba Triad Group

Dosage form: enema
Ingredients: mineral oil 118mL in 118mL
Labeler: H and P Industries, Inc. dba Triad Group
NDC Code: 50730-2113

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.

Drug Facts

Active ingredient

Mineral Oil, 100%

Purpose

Lubricant Laxative

Use
  • For relief of occasional constipation. This product generally produced bowel movement in 2 to 15 minutes.

Warnings

For rectal use only.

Do not use
  • If you have abdominal pain, nausea, or vomiting, unless directed by a doctor.
  • Longer than one week unless directed by a doctor.
  • More than one enema per day unless directed by a doctor.

Ask a doctor before use
  • if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks




Stop use and ask a doctor if
  • use results in unusual pain or other side effects.
  • you have rectal bleeding or failure to have a bowel movement after use of a laxative. This 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 Single Daily Dose

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

Adults and children
12 years and older
One bottle (4 oz.)
120 mL delivered dose
Children 2 years to
12 years old
1/2 Adult dose (2 oz.)
60 mL delivered dose
Children under
2 years of age
Ask a doctor












Dosage:
  • Adults and children 12 years of age and older: rectal enema dosage is 120 milliliters in a single daily dose.
  • Children 2 to 12 years of age: rectal enema dosage is 60 mililiters in a single daily dose, 1/2 of a bottle. (Children's dose of 60 mililiters can be measured by removing mineral oil from the bottle until the words "Mineral Oil" on the front face of the bottle are just covered).
  • Children under 2 years of age: ask a doctor.
Directions for inserting enema
Positioning:


Left side position: Lie on left side with right knee bent and arms resting comfortably.

Knee chest position: Kneel, lower head and chest forward until left side of the face is resting on surface with arms resting comfortably.

CAUTION: Remove orange protective shield before inserting. To do so, hold bottle upright with one hand and pull gently to remove.

  • with steady pressure, gently insert enema tip into rectum with a side to side movement with tip pointing toward navel.
  • stop using if tip is hard to insert. Forcing tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • Squeeze bottle until nearly all the liquid is released. Remove from rectum. Maintain position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.


Other Information

This product does not contain Dry Natural Rubber or Natural Rubber Latex.




Principal Display PanelTRIAD

Ready-To-Use
MINERAL OIL
enema, USP

protective shield prevents contamination

lubricated tip assures ease of insertion

one way safety valve prevents reflux

easy to grip and squeeze bottle

carton sealed for safety

4 1/2 fl. oz. (133 ml)

CAT. No. 10-2113
Triad Disposables
Brookfield, WI 53045

ENEMA 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-2113
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 Description
1NDC:50730-2113-01 BOTTLE (BOTTLE) in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/22/1996
Labeler - H and P Industries, Inc. dba Triad Group (050259597)
Registrant - H and P Industries, Inc. dba Triad Group (050259597)
Establishment
NameAddressID/FEIOperations
H and P Industries, Inc. dba Triad Group050259597manufacture

 
H and P Industries, Inc. dba Triad Group

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Medically reviewed on Nov 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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