PEN PREP PLUS - magnesium citrate powder, for solution 
PEN Prep LLC

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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OTC ACTIVE INGREDIENT SECTION

DRUG FACTS ACTIVE INGREGIENT (IN EACH DOSE) MAGNESIUM CITRATE 17 G   SIMETHICONE 80 MG

INACTIVE INGREDIENT SECTION

SUCRALOSE, LEMON FLAVOR

INDICATIONS AND USES

RELIEVES OCCASIONAL CONSTIPATION (IRREGULARITY)

DOSAGE AND ADMINISTRATION SECTION

FILL THIS BOTTLE TO THE TOP OF THE LABEL WITH COLD WATER OR OTHER LIQUIDS AND SHAKE THOROUGHLY. IF NEEDED, REFRIGERATE AFTER RECONSTITUTING, AND THEN SHAKE BEFORE USE. DO NOT USE AFTER 36 HOURS OF RECONSTITUTION. OR USE AS DIRECTED BY YOUR DOCTOR. CHILDREN UNDER 12, ASK YOUR DOCTOR.

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

PURPOSE SECTION

SALINE LAXATIVE  REDUCTION OF INTESTINAL GAS

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PEN PREP TM  CITRATE OF MAGNESIUM PLUS  10 FL. OZ. AFTER RECONSTITUTION

OTHER INFORMATION: TAMPER EVIDENT: DO NOT USE IF TAMPER-PROOF CAP IS OPEN OR BROKEN.

QUESTIONS OR COMMENTS? 956-605-7590  PEN PREP L.L.C. MCALLEN, TEXAS 78504  WWW.PENRGV.COM

PEN PREP PLUS LABEL

PEN PREP PLUS 
magnesium citrate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76334-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE17 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE .08 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (LEMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76334-002-0217 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/01/2010
Labeler - PEN Prep LLC (968345434)
Registrant - PEN Prep LLC (968345434)

Revised: 11/2011
Document Id: 411ab635-a095-416a-b679-e0b4c4e3dcf8
Set id: fe4525a0-8d44-48c7-b93a-84c98e3799d0
Version: 2
Effective Time: 20111122
 
PEN Prep LLC