ENEMA MINERAL OIL- mineral oil enema

Enema Mineral Oil by

Drug Labeling and Warnings

Enema Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

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)

INGREDIENTS AND APPEARANCE

ENEMA MINERAL OIL 
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-019
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	118 g  in 118 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-019-01	1 in 1 CARTON	01/05/2013
1		133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/05/2013

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-019)