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NDC 63736-0042-16 Kondremul 2.12 g/5mL Details

Kondremul 2.12 g/5mL

Kondremul is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is MINERAL OIL.

Product Information

NDC	63736-0042
Product ID	63736-042_40c69006-355b-4847-a036-4f7243580778
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kondremul
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	2.12
Active Ingredient Units	g/5mL
Substance Name	MINERAL OIL
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63736-0042-16 (63736004216)

Pricing Information	N/A
NDC Package Code	63736-042-16
Billing NDC	63736004216
Package	480 mL in 1 BOTTLE (63736-042-16)
Marketing Start Date	2009-06-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fca59a65-5eaf-41dd-8ef6-7928c209189e Details

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

Ask a doctor or pharmacist before use if you are

presently taking a stool softener laxative

When using this product

do not take with meals

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

If breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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, Mapleine Triple Oil, Purified Water, Titanium Dioxide, Vanillin

Questions?

1-800-344-7239

PRINCIPAL DISPLAY PANEL

KONDREMUL®

LUBRICANT LAXATIVE

Mineral Oil (microemulsion)

16 FL. OZ. (480 ML)

INGREDIENTS AND APPEARANCE

KONDREMUL

mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-042
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2.12 g in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Acacia (UNII: 5C5403N26O)
Benzoic Acid (UNII: 8SKN0B0MIM)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ETHYL VANILLIN (UNII: YC9ST449YJ)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color	white (Opaque white)	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63736-042-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/05/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 12/2021

Document Id: 40c69006-355b-4847-a036-4f7243580778

Set id: fca59a65-5eaf-41dd-8ef6-7928c209189e

Version: 3

Effective Time: 20211216