SUNMARK MINERAL OIL LAXATIVE- mineral oil enema

Sunmark Mineral Oil by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral Oil 100%

Purpose

Lubricant laxative

Use

• for relief of occasional constipation

Warnings

For rectal use only.

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

Stop use and ask a doctor if you have:

• rectal bleeding
• no bowel movement after use

These symptoms may indicate a serious condition.

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

Keep out of reach of children.

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

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

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Distributred By McKesson
One Post Street, San Francisco, CA 94104

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)

INGREDIENTS AND APPEARANCE

SUNMARK MINERAL OIL  LAXATIVE
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-185
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: 49348-185-20	1 in 1 CARTON	11/13/2002
1		133 mL in 1 BOTTLE; 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	11/13/2002

Labeler - McKesson (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(49348-185)