Otc Active Ingredient Section
DRUG FACTS ACTIVE INGREDIENT (IN EACH DOSE) MAGNESIUM CITRATE 17 G
Pen Prep
FDA Label NDC 76334-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pen Prep Llc for the product Pen Prep (NDC 76334-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc active ingredient section, purpose section, keep out of reach of children section, indications and uses, warnings section, dosage and administration section, inactive ingredient section, package label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Pen Prep Label (Penprep Label)
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