FDA Label for Pen Prep Plus
View Indications, Usage & Precautions
Pen Prep Plus Product Label
The following document was submitted to the FDA by the labeler of this product Pen Prep Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.