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Drug Facts
Enema Mineral Oil
FDA Label NDC 67234-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natureplex Llc for the product Enema Mineral Oil (NDC 67234-019). 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 other, active ingredient (in each 120 ml delivered dose), purpose, use, warnings, caution, do not use, ask a doctor before use if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 120 Ml Delivered Dose)
Mineral oil 100%
Purpose
Lubricant laxative
Use
- for relief of occasional constipation
- this product generally produces bowel movement in 2 to 15 minutes
Warnings
For rectal use only.
Caution
To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.
Do Not Use
- on children under 13 years of age
- on pregnant women
- on persons with difficulty swallowing
- on bedridden patients
- if you are presently taking a stool softener laxative
- or take with meals
Ask A Doctor Before Use If You
- have already used a laxative for more than 3 days
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits that persist over a period of 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you have no bowel movement within 30 minutes of enema use
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.
Otc - 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: 800-222-1222.
Directions (Or As Directed By A Doctor)
Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours).
| Adults & children 13 years old and older | 1 bottle |
| Children under 13 years old | DO NOT USE |
Other Information
- Store at 15 to 30°C (59 to 86°F).
- Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredient
None
Questions Or Comments?
1-866-323-0107 or www.natureplex.com
Principal Display Panel - 133 Ml Bottle Carton
*Compare To Fleet® Mineral Oil Enema
Natureplex™
READY TO USE
Enema
Mineral
Oil
Sodium
Free
For
Relief Of
Occasional
Constipation
Not Made
With
Natural
Rubber
Latex
Soft,
Easy To
Use
Bottle
NDC 67234-019-01
1
Bottle
4.5 Fl Oz
(133 mL)
Principal Display Panel (133 mL Bottle Carton)
* Please review the disclaimer below.
