SUNMARK- mineral oil 
ATLANTIC BIOLOGICALS CORP.

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Mineral Oil

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

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

image 1

SUNMARK 
mineral oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0832(NDC:49348-831)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL999 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0832-150 in 1 BOX, UNIT-DOSE05/20/2024
1NDC:17856-0832-230 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM04/10/201907/18/2025
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-0832)

Revised: 5/2024
Document Id: 2d7dbcdf-ec8e-49c1-9e4d-97faad912c03
Set id: e95248fd-c26b-436c-bf62-b9c6790c2e91
Version: 4
Effective Time: 20240520
 
ATLANTIC BIOLOGICALS CORP.