Otc - Active Ingredient
ARSENICUM ALBUM 9C (0.8MG), CINCHONA OFFICINALIS 5C (0.8MG), PODOPHYLLUM PELTATUM 9C (0.8MG)**
Diaralia Tablet
FDA Label NDC 0220-9095
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Diaralia (NDC 0220-9095). 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, indications & usage, otc - purpose, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
TEMPORARILY RELIEVES THE SYMPTOMS OF DIARRHEA INCLUDING: TRAVELER'S DIARHEA, INTESTINAL PAIN, BLOATING, GAS, NAUSEA, VOMITING
Otc - Purpose
ARSENICUM ALBUM 9C (0.8MG) RELIEVES DIARRHEA WITH VOMITING AND WEAKNESS*
(CONTAINS LESS THAN 10 -18 MG ARSENIC)
CINCHONA OFFICINALIS 5C (0.8MG) RELIEVES DIARRHEA WITH GAS AND BLOATING*
(CONTAINS LESS THAN 10 -11 MG ALKALOIDS)
PODOPHYLLUM PELTATUM 9C (0.8MG) RELIEVES DIARRHEA WITH INTESTINAL RUMBLING AND PAIN*
(CONTAINS LESS THAN 10 -19 MG PODOPHYLLOTOXIN)
Otc - Stop Use
ASK A DOCTOR BEFORE USE IF YOU HAVE FEVER, BLOODY OR BLACK STOOL, MUCUS IN YOUR STOOL.
STOP USE AND ASK DOCTOR IF SYMPTOMS PERSIST FOR MORE THAN 2 DAYS OR WORSEN.
Otc - Pregnancy Or Breast Feeding
IF PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Dosage & Administration
DRINK PLENTY OF CLEAR FLUIDS TO HELP PREVENT DEHYDRATION CAUSED BY DIARRHEA.
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER: AT THE ONSET OF SYMPTOMS, ALLOW 2 TABLETS TO DISSOLVE UNDER THE TONGUE EVERY 4 TO 6 HOURS, UP TO 2 DAYS MAXIMIUM. DISCONTINUE USE AS SOON AS SYMPTOMS DISAPPEAR.
CHILDERN UNDER 6 YEARS OF AGE: ASK A DOCTOR.
Other
DO NOT USE IF GLUED CARTON END FLAPS ARE OPEN OR IF THE BLISTER SEAL IS BROKEN.
CONTAINS 60 MELTAWAY TABLETS
STORE BELOW 86° F (30° C)
THE LETTERS "HPUS" INDICATE THAT THE COMPONENTS IN THIS PRODUCT ARE OFFICIALLY MONOGRAPHED IN THE HOMEOPATHIC PHARMACOPOEIA OF THE UNITED STATES.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Inactive Ingredient
LACTOSE, CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Package Label.Principal Display Panel
Image (Diaralia)
* Please review the disclaimer below.
