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NDC 49348-0831-43 Sunmark 999 mg/mL Details

Sunmark 999 mg/mL

Sunmark is a ORAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is MINERAL OIL.

Product Information

NDC	49348-0831
Product ID	49348-831_a0f6454d-16f0-4473-ad5f-fb3e6cb7a03c
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	Sunmark
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	ORAL
Active Ingredient Strength	999
Active Ingredient Units	mg/mL
Substance Name	MINERAL OIL
Labeler Name	Strategic Sourcing Services 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 49348-0831-43 (49348083143)

Pricing Information	N/A
NDC Package Code	49348-831-43
Billing NDC	49348083143
Package	473 mL in 1 BOTTLE, PLASTIC (49348-831-43)
Marketing Start Date	2002-11-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a920642d-02ed-4d10-92b0-94ad83d83a1f 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)

Adverse reaction

Another Quality Product Distributed by McKesson

One Post Street

San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

principal display panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

SUNMARK

mineral

oil U.S.P.

Lubricant Laxative

For relief of occasional constipation

Odorless - Tasteless - Colorless

16 FL OZ ( 1 PT) 473 mL

INGREDIENTS AND APPEARANCE

SUNMARK

mineral oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-831
Route of Administration	ORAL

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:49348-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/13/2002

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49348-831)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49348-831)

Revised: 3/2022

Document Id: a0f6454d-16f0-4473-ad5f-fb3e6cb7a03c

Set id: a920642d-02ed-4d10-92b0-94ad83d83a1f

Version: 15

Effective Time: 20220317