Sunmark®

Sunmark®
SPL v5
SPL
SPL Set ID c54f7df2-3845-425f-b13e-3dc000123f3c
Route
RECTAL
Published
Effective Date 2025-01-14
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 2002-11-13

Description

Drug Facts

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

Drug Facts

Use
  • for relief of occasional constipation
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 50566-9

Stop use and ask a doctor if you have:

  • rectal bleeding
  • no bowel movement after use

These symptoms may indicate a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For rectal use only.

Directions

Single daily dosage

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and over 1 bottle
Children 2 to under 12 years old 1/2 bottle once daily
Children under 2 years DO NOT USE
Other Information
  • store at 15 to 30°C (59 to 86°F)
  • this product generally produces a bowel movement in 1-5 minutes
  • carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.
Inactive Ingredients

none

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel 133 Ml Bottle Carton

sunmark®

COMPARE TO FLEET®

MINERAL OIL ENEMA

ACTIVE INGREDIENT*

NDC 49348-185-20

complete

ready-to-use

enema

Mineral Oil

Sodium free lubricant

laxative for relief of

occasional constipation

Comfortable,

lubricated tip

Works in minutes

NOT MADE WITH

NATURAL RUBBER

LATEX

4.5 FL OZ

(133 ml)

Active Ingredient (in Each 118 Ml Delivered Dose)

Mineral Oil 100%


Structured Label Content

Use
  • for relief of occasional constipation
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 50566-9 (50566-9)

Stop use and ask a doctor if you have:

  • rectal bleeding
  • no bowel movement after use

These symptoms may indicate a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Lubricant laxative

Warnings

For rectal use only.

Directions

Single daily dosage

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and over 1 bottle
Children 2 to under 12 years old 1/2 bottle once daily
Children under 2 years DO NOT USE
Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • this product generally produces a bowel movement in 1-5 minutes
  • carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton)

sunmark®

COMPARE TO FLEET®

MINERAL OIL ENEMA

ACTIVE INGREDIENT*

NDC 49348-185-20

complete

ready-to-use

enema

Mineral Oil

Sodium free lubricant

laxative for relief of

occasional constipation

Comfortable,

lubricated tip

Works in minutes

NOT MADE WITH

NATURAL RUBBER

LATEX

4.5 FL OZ

(133 ml)

Active Ingredient (in Each 118 Ml Delivered Dose) (Active ingredient (in each 118 mL delivered dose))

Mineral Oil 100%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)