MINERAL OIL- mineral oil oil 
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Mineral oil 100%

Purpose

Intestinal lubricant

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours

Warnings

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

Ask a doctor before use if you have

  • stomach reflux
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or 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 (1-800-222-1222) immediately.

Directions

  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses
 age dose
 adults & children over 12 years1 to 3 tablespoons (15 to 45 mL) maximum 3 tablespoons (45 mL) in 24 hours
 children under 12 yearsconsult a doctor

Other information

  • keep tightly closes
  • protect from sunlight

Inactive ingredients

d-alpha tocopherol (Vitamin E) as stabilizer

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Extra Heavy

Mineral Oil

Intestinal lubricant

Tasteless • Odorless • Colorless

An Effective Intestinal Lubricant for use in the Treatment of Constipation

FL OZ (pt.) mL

Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 710603 USA

AC (870) 535-3635  MADE IN THE U.S.A.

TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP PRINTED SAFETY FOIL IS BROKEN OR MISSING.

Package Label

Mineral Oil

Select Brand Mineral Oil

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-334
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-334-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/200912/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33409/25/200912/31/2020
Labeler - Select Brand Dist. (012578514)

Revised: 10/2019
Document Id: 5373df43-a94b-43f4-b41b-1c0af2fa9d33
Set id: a8e303cc-52c4-4605-8ca4-ec291fc56bba
Version: 2
Effective Time: 20191017
 
Select Brand Dist.