Label: MINERAL OIL oil
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-190-16 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 31, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose:
- Uses
- Warnings
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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 of pharmamcist 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 drugs
- Laxatives may affect how other drugs work
- When using this product
- Stop use and ask a doctor
- If pregnant or breast feeding,
- Keep out of the reach of children
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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 and children over 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum 3 tablespoons (45mL) in 24 hours
children 6 years to under 12 years 1 to 3 teaspoons(15 to 45 ml)
maximum 3 teaspoons (45mL) in 24 hours
Children under 6 years Do not use, consult a doctor
- Other Information
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MINERAL OIL
mineral oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 471.9528 g in 472 mL Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-190-16 472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/31/2015 Labeler - Geritrex LLC (112796248) Registrant - Geritrex LLC (112796248) Establishment Name Address ID/FEI Business Operations Geritrex LLC 112796248 repack(54162-190) Establishment Name Address ID/FEI Business Operations Calumet Penreco LLC 114222776 manufacture(54162-190)
