Kondremul

Manufacturer: Insight Pharmaceuticals
Effective date: 2010-01-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:23:47

Label at a glance#

ProductKondremul

Active ingredientMineral Oil

Label structure10 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#

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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 SECTION

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

OTC - WHEN USING SECTION

When using this product do not take with meals

OTC - STOP USE SECTION

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 - PREGNANCY OR BREAST FEEDING SECTION

If breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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, Mapliene Triple Oil, Purified Water, Titanium Dioxide, Vanillin

QUESTIONS

OTC - QUESTIONS SECTION

Call 1-800-344-7239

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63736-012-16	2019-10-21	C162847	48780-1	956f9ecf-ccd2-621f-e053-dbdaa90a74ad	KONDREMUL ® LUBRICANT LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-012-16	Kondremul	480 mL in 1 BOTTLE	LIQUID	480		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-012	KONDREMUL LIQUID [INSIGHT PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20100302_116e0ea5-c649-47ef-a9d2-fc683aed229c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	2
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	2
Acacia	INACTIVE INGREDIENT	5C5403N26O	2
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Kondremul
Mineral Oil
Water
Acacia
Glycerin
Benzoic Acid
Titanium Dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63736-012	63736-012-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Mineral Oil	T5L8T28FGP	ACTIB
Water	059QF0KO0R	IACT
Acacia	5C5403N26O	IACT
Glycerin	PDC6A3C0OX	IACT
Benzoic Acid	8SKN0B0MIM	IACT
Titanium Dioxide	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Acacia	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SOLUTION / ORAL		100 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / RECTAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates

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
457b3442-1ba2-419d-b50c-d8eb48a92072			116e0ea5-c649-47ef-a9d2-fc683aed229c	2026-05-28	Warnings	Exact identifier spl set id: 116e0ea5-c649-47ef-a9d2-fc683aed229c

Reported adverse events (FAERS/openFDA)#

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