Label: ENEMA- mineral oil enema
- NDC Code(s): 50730-2113-0
- Packager: H and P Industries, Inc. dba Triad Group
- Category: HUMAN OTC DRUG LABEL
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.
Updated November 3, 2009
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- Active ingredient
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.
Single Daily Dose
Do not use more unless directed by a doctor.
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
2 years of age
Ask a doctor
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.
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.
- Adults and children 12 years of age and older: rectal enema dosage is 120 milliliters in a single daily dose.
- Other Information
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- Principal Display Panel
INGREDIENTS AND APPEARANCE
mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-2113 Route of Administration RECTAL 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:50730-2113-0 1 in 1 BOX 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/22/1996 Labeler - H and P Industries, Inc. dba Triad Group (050259597) Registrant - H and P Industries, Inc. dba Triad Group (050259597) Establishment Name Address ID/FEI Business Operations H and P Industries, Inc. dba Triad Group 050259597 manufacture