FDA Label for Enema Mineral Oil
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 120 ML DELIVERED DOSE)
- PURPOSE
- USE
- WARNINGS
- CAUTION
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS (OR AS DIRECTED BY A DOCTOR)
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 133 ML BOTTLE CARTON
Enema Mineral Oil Product Label
The following document was submitted to the FDA by the labeler of this product Natureplex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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)
* Please review the disclaimer below.