Label: PEN PREP PLUS- magnesium citrate powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 76334-002-02 - Packager: PEN Prep LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 22, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- OTC ACTIVE INGREDIENT SECTION
- INACTIVE INGREDIENT SECTION
- INDICATIONS AND USES
- DOSAGE AND ADMINISTRATION SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
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WARNINGS SECTION
WARNINGS: ALLERGY ALERT: DO NOT USE IF YOU ARE ALLERGIC TO MAGNESIUM CITRATE OR SIMETHICONE. DO NOT EXCEED MAXIMUM DOSE IN A 24 HOUR PERIOD. ASK A DOCTOR BEFORE USE IF YOU HAVE KIDNEY DISEASE NAUSEA, VOMITING OR ABDOMINAL PAIN A SUDDEN CHANGE OF BOWEL HABITS FOR OVER 2 WEEKS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING A PRESCRIPTION DRUG. TAKE THIS PRODUCT TWO OR MORE HOURS BEFORE OR AFTER OTHER DRUDS. WHEN USING THIS PRODUCT YOU MAY HAVE LOOSE, WATERY, MORE FREQUENT STOOLS. - PREGNANCY OR BREAST FEEDING SECTION
- PURPOSE SECTION
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEN PREP PLUS
magnesium citrate powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76334-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE 17 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE .08 g in 100 g Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor LEMON (LEMON FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76334-002-02 17 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 07/01/2010 Labeler - PEN Prep LLC (968345434) Registrant - PEN Prep LLC (968345434)
