4718 Enema, Mineral Oil 67777-430-01

4718 Enema, Mineral Oil 67777-430-01
SPL v3
SPL
SPL Set ID 9e51c852-9477-5cf5-e053-2a95a90a97db
Route
RECTAL
Published
Effective Date 2020-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (133 g)

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-26
Description

Mineral Oil 100%

Purpose

Lubricant Laxative

Medication Information

Purpose

Lubricant Laxative

Description

Mineral Oil 100%

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

Enema, Mineral Oil, 4718

Warnings

For rectal use only.

Directions
  • Adults and children 12 years old and older: 1 bottle daily.
  • Children from 2 to under 12 years of age: 1/2 bottle once daily.
  • Children under 2 years old: Consult a doctor.
Do Not Use
  • Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
  • Longer than one week unless directed by a doctor.
Questions?
  • 1-888-Dynarex
Active Ingredient

Mineral Oil 100%

Other Information
  • Store at room temperature.
Stop Use and Ask A Doctor If
  • You have rectal bleeding or fail to have a bowel movement after use.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Ask A Doctor Before Use If You Have
  • Noticed a sudden change in bowel habits that persists over a period of two weeks.

Structured Label Content

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

Enema, Mineral Oil, 4718

Purpose

Lubricant Laxative

Warnings

For rectal use only.

Directions
  • Adults and children 12 years old and older: 1 bottle daily.
  • Children from 2 to under 12 years of age: 1/2 bottle once daily.
  • Children under 2 years old: Consult a doctor.
Do Not Use (Do not use)
  • Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
  • Longer than one week unless directed by a doctor.
Questions?
  • 1-888-Dynarex
Active Ingredient

Mineral Oil 100%

Other Information (Other information)
  • Store at room temperature.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • You have rectal bleeding or fail to have a bowel movement after 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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Noticed a sudden change in bowel habits that persists over a period of two weeks.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.023080 · Updated: 2026-03-14T23:05:17.700396