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NDC 50804-0831-43 Mineral Oil 999 mg/mL Details

Mineral Oil 999 mg/mL

Mineral Oil is a ORAL; TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is MINERAL OIL.

Product Information

NDC	50804-0831
Product ID	50804-831_d7997cc3-c797-45b7-ab0a-9f9259132f92
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	LIQUID
Route	ORAL; TOPICAL
Active Ingredient Strength	999
Active Ingredient Units	mg/mL
Substance Name	MINERAL OIL
Labeler Name	Perrigo Direct, Inc.
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 50804-0831-43 (50804083143)

Pricing Information	N/A
NDC Package Code	50804-831-43
Billing NDC	50804083143
Package	473 mL in 1 BOTTLE, PLASTIC (50804-831-43)
Marketing Start Date	1994-08-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f1656280-fad9-4922-9d5c-be774a8b1422 Details

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

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

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 persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking a stool softener laxative
taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work

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 professional before use

Keep out of reach of children

in case of overdose, get medical help or contact a Poison Control Center 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 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

keep tightly closed. Protect from sunlight

Inactive ingredients

mixed tocopherols (added as a stabilizer)

SPL UNCLASSIFIED SECTION

Distributed By: Perrigo Direct, Inc.

Peachtree City, GA 30269

www. PerrigoDirect.com

1-888-593-0593

principal display panel

NDC 50804-831-43

GOODSENSE

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Mineral Oil USP

Lubricant Lazative

For relief of occasional constipation

ODORLESS TASTELESS COLORLESS

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

MINERAL OIL

mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-831
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	999 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/05/1994

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	08/05/1994

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-831)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-831)

Revised: 9/2022

Document Id: d7997cc3-c797-45b7-ab0a-9f9259132f92

Set id: f1656280-fad9-4922-9d5c-be774a8b1422

Version: 11

Effective Time: 20220921