Enema Mineral Oil

Enema Mineral Oil
SPL v5
SPL
SPL Set ID 44ded8db-cace-416a-a15f-921fcdaa11bd
Route
RECTAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (118 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-05

Description

Drug Facts

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

Drug Facts

Use
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

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

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.

Warnings

For rectal use only.

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
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

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
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
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
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)

Active Ingredient (in Each 120 Ml Delivered Dose)

Mineral oil 100%


Structured Label Content

Use
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

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

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.

Purpose

Lubricant laxative

Warnings

For rectal use only.

Do Not Use (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
Other Information (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 (Inactive ingredient)

None

Questions Or Comments? (Questions or comments?)

1-866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
Ask A Doctor Before Use If You (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
Directions (or As Directed By A Doctor) (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
Principal Display Panel 133 Ml Bottle Carton (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)

Active Ingredient (in Each 120 Ml Delivered Dose) (Active ingredient (in each 120 ml delivered dose))

Mineral oil 100%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)