Search by Drug Name or NDC

NDC 48433-0202-30 Mineral Oil 1000 mg/mL Details

Mineral Oil 1000 mg/mL

Mineral Oil is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Safecor Health, LLC. The primary component is MINERAL OIL.

Product Information

NDC	48433-0202
Product ID	48433-202_2adb5217-ebbe-408a-a271-2bd8a5f282f2
Associated GPIs	46400010001700
GCN Sequence Number	002997
GCN Sequence Number Description	mineral oil OIL ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09020
HICL Sequence Number	001319
HICL Sequence Number Description	MINERAL OIL
Brand/Generic	Generic
Proprietary Name	Mineral Oil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	1000
Active Ingredient Units	mg/mL
Substance Name	MINERAL OIL
Labeler Name	Safecor Health, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 48433-0202-30 (48433020230)

Pricing Information	N/A
NDC Package Code	48433-202-30
Billing NDC	48433020230
Package	30 mL in 1 CUP, UNIT-DOSE (48433-202-30)
Marketing Start Date	2014-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ef182484-692e-4eb3-bcf1-3c990ec0d08e Details

Active Ingredients

Mineral Oil USP

Purpose

Lubricant Laxative

Use:

For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours

WARNINGS:

Do not use * if you have difficulty swallowing * in children under 6 years of age * if you are pregnant * for a period longer than 1 week * if you are bedridden or aged.

Ask a doctor before use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.

Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.

When using this product: Do not take with meals. Take only at bedtime.

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

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

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.

SPL UNCLASSIFIED SECTION

Directions: * Do not take with meals. Take only at bedtime. May be taken as a single daily dose or in divided doses.
Adults and children 12 years of age and over	1 to 3 Tablespoons (15 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours
Children 6 to under 12 years of age	1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours
Children under 6 years	Do not use. Consult a doctor

Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.

Inactive ingredients: Mixed tocopherols (added as a stabilizer)

NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204

Rev: 05/2019 PN5471

Principal Display Panel - Lid Label

Delivers 30 mL

NDC 48433-202-30

Mineral Oil USP

Lubricant Laxative

DO NOT TAKE WITH MEALS

348433202302

Pkg By: Safecor Health, LLC

Columbus, OH 43204

INGREDIENTS AND APPEARANCE

MINERAL OIL

mineral oil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48433-202
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1000 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48433-202-30	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	10/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/01/2014

Labeler - Safecor Health, LLC (828269675)

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		078805287	MANUFACTURE(48433-202)

Revised: 1/2022

Document Id: 2adb5217-ebbe-408a-a271-2bd8a5f282f2

Set id: ef182484-692e-4eb3-bcf1-3c990ec0d08e

Version: 2

Effective Time: 20220126