Label: KONDREMUL liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 63736-012-16 - Packager: Insight Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL/teaspoonful)
- Purpose
- Uses
-
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
-
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
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
Do Not Purchase if perforated ring
at bottom of cap is broken or missing.KONDREMUL®
LUBRICANT LAXATIVEMineral 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 liquidProduct 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)