Sunmark by ATLANTIC BIOLOGICALS CORP. SUNMARK- mineral oil

Sunmark by

Drug Labeling and Warnings

Sunmark by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 section

DISTRIBUTED BY:

ALTANTIC BIOLOGICALS CORP.

20101 NE 16TH PLACE

MIAMI, FL 33179

Principal Display Panel

Mineral Oil USP

Lubricant Laxative

For relief of occasional constipation

Tasteless, Odorless, Colorless

30mL CUP 

NDC: 17856-0832-01

INGREDIENTS AND APPEARANCE

SUNMARK 
mineral oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0832(NDC:49348-831)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	999 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0832-1	50 in 1 BOX, UNIT-DOSE	04/10/2019
1		30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/10/2019

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	relabel(17856-0832) , repack(17856-0832)