Label: MINERAL OIL solution
- NDC Code(s): 48433-202-30
- Packager: Safecor Health, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 8, 2025
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- 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 Drug M334 10/01/2014 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 MANUFACTURE(48433-202)