LEADER MINERAL OIL- mineral oil liquid 
Cardinal Health, 110 dba Leader

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LEADER Mineral Oil

Mineral Oil

Lubricant Laxative

For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

and consult a doctor if there is a fialure to have a bowel movement after use.

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.


Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

Children under 6 yrs of age: Consult a doctor before use

dl-alpha-tocopherol as a preservative

Keep tightly closed and protected from direct light

mineraloil

LEADER MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0448
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1000 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0448-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00712/18/2018
Labeler - Cardinal Health, 110 dba Leader (063997360)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114analysis(70000-0448) , manufacture(70000-0448) , pack(70000-0448) , label(70000-0448)

Revised: 12/2023
Document Id: 0d19a0a5-ed0d-1796-e063-6294a90a7e8f
Set id: 7d4f8fa3-8203-5523-e053-2991aa0aba1a
Version: 5
Effective Time: 20231222
 
Cardinal Health, 110 dba Leader