FDA Label for Kondremul

View Indications, Usage & Precautions

Kondremul Product Label

The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are presently taking a stool softener laxative


Otc - When Using



When using this product do not take with meals


Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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


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


* Please review the disclaimer below.