KONDREMUL- mineral oil liquid

Kondremul by

Drug Labeling and Warnings

Kondremul by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL/teaspoonful)

Mineral Oil 2.5 mL

Purpose

Lubricant laxative

Uses

• relieves occasional constipation
  
• generally produces bowel movement in 6 to 8 hours

Warnings

Do not use

for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing.

Ask a doctor before use if you have

• abdominal pain, nausea or vomiting.
  
• a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking a stool softener laxative

When using this product

do not take with meals

Stop use and ask a doctor if

• you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.
  
• you need to use this product more than 1 week

If breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not take with meals
  
• shake well before using
  
• adults and children 12 years of age and over: 6–18 teaspoons per day or as directed by a doctor
  
• children 6 to under 12 years of age: 2–6 teaspoons per day or as directed by a doctor
  
• the maximum daily dose may be taken as a single dose or divided in up to 3 equal parts
  
• children under 6 years of age: consult a doctor

Inactive ingredients

Acacia, Benzoic Acid, Carrageenan (Irish Moss), Ethyl Vanillin, Glycerin, Mapleine Triple Oil, Purified Water, Titanium Dioxide, Vanillin

Questions?

1-800-344-7239

PRINCIPAL DISPLAY PANEL

KONDREMUL® 
LUBRICANT LAXATIVE

Mineral Oil (microemulsion)

16 FL. OZ. (480 ML)

INGREDIENTS AND APPEARANCE

KONDREMUL 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2.12 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Acacia (UNII: 5C5403N26O)
Benzoic Acid (UNII: 8SKN0B0MIM)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ETHYL VANILLIN (UNII: YC9ST449YJ)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color	WHITE (Opaque white)	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-042-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	06/05/2009

Labeler - Insight Pharmaceuticals LLC (055665422)