Kondremul
FDA Label NDC 63736-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Kondremul (NDC 63736-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml/teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principle Display Panel (480 mL Bottle Label)

Principle Display Panel (480 mL Bottle Label)

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