Kondremul by Insight Pharmaceuticals KONDREMUL liquid

Kondremul by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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 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, Mapliene Triple Oil, Purified Water, Titanium Dioxide, Vanillin

QUESTIONS

Call 1-800-344-7239

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Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

Do Not Purchase if perforated ring
at bottom of cap is broken or missing.

KONDREMUL®
LUBRICANT LAXATIVE

Mineral Oil (microemulsion)

FOR RELIEF OF OCCASIONAL CONSTIPATION

Promotes gentle, predictable regularity of normal
bowel movement. Creamy liquid pours easily and
leaves no oily aftertaste. All dosages may be
administered plain or mixed with warm or cold water,
milk or cocoa. Pleasant tasting and smooth acting, it
passes through stomach and upper intestine without
upset or dehydration. Assures soft stool by retaining
moisture balance and mixing thoroughly with bowel
content. Permits passage of stool without straining.

SHAKE WELL BEFORE USING

Store at room temperature 15°-25°C (59°-77°F)

16 FL. OZ. (480 ML)

69871C

INGREDIENTS AND APPEARANCE

KONDREMUL 
kondremul liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	2.5 mL  in 5 mL

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

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: 63736-012-16	480 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part334	06/05/2009

Labeler - Insight Pharmaceuticals (176792315)