Kondremul

Manufacturer: Insight Pharmaceuticals LLC
Effective date: 2023-08-18
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:27:15

Label at a glance#

ProductKondremul

Active ingredientMINERAL OIL

Label structure9 sections

Indications and uses

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

Dosage and administration

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-344-7239

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL/teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 2.5 mL

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a stool softener laxative

When using this product

OTC - WHEN USING SECTION

do not take with meals

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-344-7239

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KONDREMUL^®
LUBRICANT LAXATIVE

Mineral Oil (microemulsion)

16 FL. OZ. (480 ML)

KONDREMUL® LUBRICANT LAXATIVE Mineral Oil (microemulsion) 16 FL. OZ. (480 ML)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63736-042-16	2021-12-14	C162847	48780-1	ab0e2407-3124-f274-e053-dbdaa90a6471	KONDREMUL - 63736-042
63736-042-16	2020-09-27	C162847	48780-1	ab0e2407-3124-f274-e053-dbdaa90a6471	KONDREMUL - 63736-042
63736-042-16	2020-09-25	C162847	48780-1	ab0e2407-3124-f274-e053-dbdaa90a6471	KONDREMUL - 63736-042
63736-042-16	2020-07-22	C162847	48780-1	ab0e2407-3124-f274-e053-dbdaa90a6471	KONDREMUL - 63736-042

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Kondremul
Mineral Oil
Acacia
Benzoic Acid
CARRAGEENAN
ETHYL VANILLIN
Glycerin
Water
Titanium Dioxide
VANILLIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63736-042	63736-042-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
Acacia	5C5403N26O	IACT
Benzoic Acid	8SKN0B0MIM	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
ETHYL VANILLIN	YC9ST449YJ	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Titanium Dioxide	15FIX9V2JP	IACT
VANILLIN	CHI530446X	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
95623362-583c-4dbe-ae90-bad39c984109			fca59a65-5eaf-41dd-8ef6-7928c209189e	2023-08-18	Warnings	Exact identifier spl id: 95623362-583c-4dbe-ae90-bad39c984109 spl set id: fca59a65-5eaf-41dd-8ef6-7928c209189e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.