Label: MINERAL OIL solution
- NDC Code(s): 48433-202-30
- Packager: Safecor Health, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 26, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use:
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WARNINGS:
Do not use * if you have difficulty swallowing * in children under 6 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 *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.
Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.
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DOSAGE & ADMINISTRATION
Directions: * Do not take with meals. Take only at bedtime. May be taken as a single daily dose or in divided doses. Adults and children 12 years of age and over 1 to 3 Tablespoons (15 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours Children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours Children under 6 years Do not use. Consult a doctor - Principal Display Panel - Lid Label
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INGREDIENTS AND APPEARANCE
MINERAL OIL
mineral oil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-202 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 1000 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-202-30 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 10/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/01/2014 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 MANUFACTURE(48433-202)
