MINERAL OIL- mineral oil liquid 
CARDINAL HEALTH 110, LLC. DBA LEADER

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Leader Mineral Oil
831.000/831AA

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.

Warnings

for this product

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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 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?

1-888-593-0593

Adverse reaction

DIST. BY CAH DUBLIn, OH 43017

www.myleader.cm

1-800-200-6313

Principal Display Panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

LEADER

NDC 70000-0663-1

Mineral Oil

Lubricant Laxative

For relief of occasional constipation

100% Money back Guarantee

Odorless, Tastekess, Colorless

Odorless Tasteless, Colorless

16 FL OZ (1PT) 473 mL

mm01

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0663
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:70000-0663-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00704/17/2023
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Registrant - Consumer Product Partners, LLC (119091520)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091514manufacture(70000-0663)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091520manufacture(70000-0663)

Revised: 2/2024
Document Id: 1182cdc0-84fc-38d4-e063-6294a90a338a
Set id: 803f444f-d136-4f06-9842-24a71a3d7d6b
Version: 2
Effective Time: 20240216
 
CARDINAL HEALTH 110, LLC. DBA LEADER