Active Ingredient
Mineral Oil 100%
4718 Enema, Mineral Oil Enema
FDA Label NDC 67777-430
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex for the product 4718 Enema, Mineral Oil (NDC 67777-430). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant Laxative
Uses
- For relief of occasional constipation.
- This product generally produces bowel movement in 2 to 15 minutes.
Warnings
For rectal use only.
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.
Ask A Doctor Before Use If You Have
- Noticed a sudden change in bowel habits that persists over a period of two weeks.
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.
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.
Other Information
- Store at room temperature.
Questions?
- 1-888-Dynarex
Label
Enema, Mineral Oil, 4718
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