Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e9381b68-296c-4450-be76-880135c8c092
Route
RECTAL
Published
Effective Date 2009-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (118 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1996-05-22
Description

Mineral Oil, 100%

Purpose

Lubricant Laxative

Medication Information

Warnings and Precautions



Purpose

Lubricant Laxative

Description

Mineral Oil, 100%

Use
  • For relief of occasional constipation. This product generally produced bowel movement in 2 to 15 minutes.
Section 44425-7


Section 50567-7



Section 50568-5



Section 51727-6


Section 53413-1



Warnings

For rectal use only.

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.
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.
Active Ingredient

Mineral Oil, 100%

Other Information

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

Ask A Doctor Before Use
  • if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks



Principal Display Panel
TRIAD



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

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.

Structured Label Content

Use
  • For relief of occasional constipation. This product generally produced bowel movement in 2 to 15 minutes.
Warnings and Precautions (34071-1)



Section 44425-7 (44425-7)


Section 50567-7 (50567-7)



Section 50568-5 (50568-5)



Section 51727-6 (51727-6)


Section 53413-1 (53413-1)



Purpose

Lubricant Laxative

Warnings

For rectal use only.

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.
Do Not Use (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.
Active Ingredient (Active ingredient)

Mineral Oil, 100%

Other Information

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

Ask A Doctor Before Use (Ask a doctor before use)
  • if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks



Principal Display Panel
TRIAD



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

Stop Use and Ask A Doctor If (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, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:57.888719 · Updated: 2026-03-14T22:52:12.899376