Label: COMBINATION PRODUCT- aconitum napellus 4x, baptisia tinctoria 4x, bryonia 4x, camphora 3x, causticum 6x, eucalyptus globulus 3x, eupatorium perfoliatum 3x, ferrum phosphoricum 8x, gelsemium sempervirens 6x, sabadilla 6x liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53346-1306-5 - Packager: PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO
- 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 May 6, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
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STOP USE
Stop use and ask a doctor if
* symptoms persist for more than 7 days (5 days for children)
* fever persists for more than 3 days
* symptoms worsen or if new symptoms occur
* redness or swelling is present, because these could be signs of a serious condition
* sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COMBINATION PRODUCT
aconitum napellus 4x, baptisia tinctoria 4x, bryonia 4x, camphora 3x, causticum 6x, eucalyptus globulus 3x, eupatorium perfoliatum 3x, ferrum phosphoricum 8x, gelsemium sempervirens 6x, sabadilla 6x liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53346-1306 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] in 50 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 4 [hp_X] in 50 mL BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA CRETICA SUBSP. DIOICA ROOT - UNII:53UB5FH7CX) BRYONIA DIOICA ROOT 4 [hp_X] in 50 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 [hp_X] in 50 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 6 [hp_X] in 50 mL EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 3 [hp_X] in 50 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 3 [hp_X] in 50 mL FERRIC PHOSPHATE (UNII: N6BAA189V1) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 8 [hp_X] in 50 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 50 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 6 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53346-1306-5 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/1986 Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612) Establishment Name Address ID/FEI Business Operations PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO 318602612 manufacture(53346-1306)