FDA.reportPublic FDA data

Enema

Manufacturer
Dynarex Corporation
Effective date
2015-02-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:41:42

Label at a glance#

ProductEnema
Active ingredientMINERAL OIL
Label structure9 sections

Indications and uses

Gentle relief of occasional constipation

Dosage and administration

Single daily dose Adults and children 12 years and older - 1 bottle Children 2 to under 12 years - 1/2 bottle Children under 2 years - Do not use. Consult a physician. How to use this enema: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove. See image on box Positioning Left-side position : L...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

Mineral Oil, 100%                    Lubricant Laxative            

Uses:

OTC - PURPOSE SECTION

  • Gentle relief of occasional constipation

Warnings:

WARNINGS SECTION

For rectal use only

As a doctor before use if you have:

OTC - ASK DOCTOR SECTION

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

  • If pregnant or breast feeding, ask a health professional before use.

Stop use and ask a doctor if:

INDICATIONS & USAGE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
  • This product produces bowel movement in 2 to 15 minutes

Directions

DOSAGE & ADMINISTRATION SECTION

Single daily dose

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

Left-side position: Lie on left side with knee bent and arms at rest.

See image on box

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

See image on box

Administering Enema

  • With steady pressure, gently insert enema with tip pointing toward navel.

  • Squeeze bottle until recommended dose is expelled (it is not necessary to

    empty unit completely. Bottle contains more liquid than needed for effective

    use. A small amount of liquid will remain in bottle after squeezing).

  • Remove tip from rectum.

  • Stop using if tip is hard to insert. Forcing the tip into the rectum can

    cause injury (especially if you have hemorrhoids). If enema tip causes

    rectal bleeding or pain, get immediatemedical care.

  • 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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral oil enema.jpg

Mineral oil enemaMineral oil enema

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN8
205121mineral oil 1000 MG/ML EnemaSCD8
205121mineral oil 100 % EnemaSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-401-012020-01-31C16284748780-19d75b9d0-b236-f424-e053-dadaa90a57ceEnema, Mineral Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-401-01Enema118 mL in 1 BOTTLEENEMA1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-401ENEMA (MINERAL OIL) ENEMA [DYNAREX CORPORATION]8Legacy NDC, 1 package rows20150213_141ff82f-ba4c-4646-8544-2350d4f85563.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP8
MINERAL OILACTIVE MOIETYT5L8T28FGP8

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
67777-40167777-401-01

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
70550386-0a48-4cd4-84c9-fc9b6e1bfc61141ff82f-ba4c-4646-8544-2350d4f855632015-02-12WarningsExact identifier
spl id: 70550386-0a48-4cd4-84c9-fc9b6e1bfc61
spl set id: 141ff82f-ba4c-4646-8544-2350d4f85563

Reported adverse events (FAERS/openFDA)#

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