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NDC 46122-0395-16 Mineral Oil 100 mg/100mL Details

Mineral Oil 100 mg/100mL

Mineral Oil is a ORAL; TOPICAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by AmerisourceBergen (Good Neighbor Pharmacy) 46122. The primary component is MINERAL OIL.

Product Information

NDC	46122-0395
Product ID	46122-395_41bfa6e2-691f-44f8-9437-951402a0d819
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	OIL
Route	ORAL; TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/100mL
Substance Name	MINERAL OIL
Labeler Name	AmerisourceBergen (Good Neighbor Pharmacy) 46122
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 46122-0395-16 (46122039516)

Pricing Information
NDC Package Code	46122-395-16
Billing NDC	46122039516
Package	473 mL in 1 BOTTLE, PLASTIC (46122-395-16)
Marketing Start Date	2016-11-30
NDC Exclude Flag	N
Price Per Unit	0.01047
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	MINERAL OIL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 581f81a0-7488-4c90-b33e-06c6301a4fd2 Details

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

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

Warnings

Do not use

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
if you are presently taking a stool softener laxative
for longer than 1 week

Ask a doctor before use if you have

abdominal pain, nausea or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks

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 pregnant or 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
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 to 45 mL)
- maximum 3 tablespoons (45 mL) in 24 hours
children under 12 years, consult a doctor

Other Information

keep tightly closed
protect from direct light

Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

SAFETY SEALED

Mineral Oil

Lubricant Laxative

Odorless-Tasteless

Crystal Clear

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

www.mygnp.com

Questions or comments? Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

Package Label

GOOD NEIGHBOR PHARMACY Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL

mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-395
Route of Administration	ORAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-395-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/30/2016

Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 11/2022

Document Id: 41bfa6e2-691f-44f8-9437-951402a0d819

Set id: 581f81a0-7488-4c90-b33e-06c6301a4fd2

Version: 4

Effective Time: 20221118