FDA.reportPublic FDA data

Enema

Manufacturer
H and P Industries, Inc. dba Triad Group
Effective date
2009-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:43

Label at a glance#

ProductEnema
Active ingredientmineral oil
Label structure7 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil, 100%

Purpose

OTC - PURPOSE SECTION

Lubricant Laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

WARNINGS SECTION

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Principal Display Panel

PACKAGE LABEL.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN1
205121mineral oil 1000 MG/ML EnemaSCD1
205121mineral oil 100 % EnemaSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50730-2113-0Enema1 in 1 BOXENEMA11
50730-2113-0Enema118 mL in 1 BOTTLEENEMA1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50730-2113ENEMA (MINERAL OIL) ENEMA [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]12 package rows20091104_e9381b68-296c-4450-be76-880135c8c092.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mineral oilACTIVE INGREDIENTT5L8T28FGP1
mineral oilACTIVE MOIETYT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50730-211350730-2113-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
mineral oilT5L8T28FGPACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
689c38f4-5b01-48bb-8dd6-3cf03faf5a29e9381b68-296c-4450-be76-880135c8c0922009-11-05WarningsExact identifier
spl set id: e9381b68-296c-4450-be76-880135c8c092

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.