Label: ITIRES- barium carbonate, calcium iodide, helianthemum canadense, conium maculatum flowering top, scrophularia nodosa, echinacea, unspecified, galium aparine, and juglans regia whole solution/ drops
- NDC Code(s): 59469-112-10, 59469-112-30
- Packager: PEKANA Naturheilmittel GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 16, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
- Dosage
- Warning
- Tamper Evident
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
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INGREDIENTS AND APPEARANCE
ITIRES
barium carbonate, calcium iodide, helianthemum canadense, conium maculatum flowering top, scrophularia nodosa, echinacea, unspecified, galium aparine, and juglans regia whole solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Barium Carbonate (UNII: 6P669D8HQ8) (Barium cation - UNII:V645272HLN) Barium Carbonate 8 [hp_X] in 50 mL Calcium Iodide (UNII: 8EKI9QEE2H) (Calcium cation - UNII:2M83C4R6ZB) Calcium Iodide 8 [hp_X] in 50 mL Helianthemum canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum canadense 12 [hp_X] in 50 mL Conium maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium maculatum Flowering Top 6 [hp_X] in 50 mL SCROPHULARIA NODOSA WHOLE (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA WHOLE - UNII:7H443NUB2T) SCROPHULARIA NODOSA WHOLE 4 [hp_X] in 50 mL Echinacea, unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, unspecified 12 [hp_X] in 50 mL GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE WHOLE - UNII:Z4B6561488) GALIUM APARINE WHOLE 6 [hp_X] in 50 mL Juglans regia Whole (UNII: 87EJ76IO83) (Juglans regia Whole - UNII:87EJ76IO83) Juglans regia Whole 6 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59469-112-10 1 in 1 BOX 12/11/2008 1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:59469-112-30 1 in 1 BOX 12/11/2008 2 100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/11/2008 Labeler - PEKANA Naturheilmittel GmbH (320344542) Establishment Name Address ID/FEI Business Operations PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(59469-112)