Search by Drug Name or NDC

NDC 63868-0831-43 Mineral Oil 99.9 mg/mL Details

Mineral Oil 99.9 mg/mL

Mineral Oil is a ORAL; TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by C.D.M.A.. The primary component is MINERAL OIL.

Product Information

NDC	63868-0831
Product ID	63868-831_802ec761-8264-4c13-953d-841a863a6d48
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	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	99.9
Active Ingredient Units	mg/mL
Substance Name	MINERAL OIL
Labeler Name	C.D.M.A.
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 63868-0831-43 (63868083143)

Pricing Information	N/A
NDC Package Code	63868-831-43
Billing NDC	63868083143
Package	473 mL in 1 BOTTLE (63868-831-43)
Marketing Start Date	2019-12-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e868a2ac-7648-4626-a8df-7e790736fbe0 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 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)

Questions?

800-935-2362

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

principal display panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

QUALITY

CHOICE

Mineral OIl

U.S.P.

Lubricant Laxative

For Relief of Occasional

Constipation

Odorless - Tasteless - Colorless

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

MINERAL OIL

mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-831
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	99.9 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:63868-831-43	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/22/2019

Labeler - C.D.M.A. (011920774)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(63868-831)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(63868-831)

Revised: 3/2022

Document Id: 802ec761-8264-4c13-953d-841a863a6d48

Set id: e868a2ac-7648-4626-a8df-7e790736fbe0

Version: 11

Effective Time: 20220314