FDA Label for Pen Prep
View Indications, Usage & Precautions
Pen Prep 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 INGREDIENT (IN EACH DOSE) MAGNESIUM CITRATE 17 G
Purpose Section
SALINE LAXATIVE
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.
Indications And Uses
RELIEVES OCCASIONAL CONSTIPATION (IRREGULARITY)
Warnings Section
WARNINGS: ALLERGY ALERT: DO NOT USE IF YOU ARE ALLERGIC TO MAGNESIUM CITRATE. 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.
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
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.
Inactive Ingredient Section
SUCRALOSE, LEMON FLAVOR
Package Label Principal Display Panel
PEN PREP TM CITRATE OF MAGNESIUM 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
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