- SPL UNCLASSIFIED SECTION
- Indications
- Dosage
- Active Ingredient
- Inactive Ingredients
- Warning
- STORAGE AND HANDLING
- Tamper Evident
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 10 ml Label
ROQUEFORTI DROPS 4X
Homeopathic Medicine 0.34 fl. oz. (10ml)
Indications: For temporary relief from digestive discomfort
Dosage: 5-10 drops, three times daily.
Active Ingredient: Penicillium roqueforti 4X
Inactive Ingredients: Purified water, sodium chloride, potassium sorbate.
Warning: If symptoms persist more than a few days, contact a licensed practitioner. As with
any drug, if you are pregnant or nursing, seek the advice of a health care professional before
using this product. Keep this and all medications out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center right away.Protect from light and heat.
Tamper Evident: Do not use product if the tamper evident strip is broken or removed from the
base of the cap.
To report serious adverse events, call: 1-877-557-4276 or 1-623-582-3110 -
INGREDIENTS AND APPEARANCE
ROQUEFORTI
penicillium roqueforti liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49693-1801 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillium roqueforti (UNII: 7ORP6R724L) (Penicillium roqueforti - UNII:7ORP6R724L) Penicillium roqueforti 4 [hp_X] in 10 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49693-1801-1 1 in 1 BOX 1 10 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/15/2009 Labeler - USPharmaCo (145322622) Establishment Name Address ID/FEI Business Operations DermaMed 256799461 MANUFACTURE