Label: COLD/FLU HP- arsenictrioxide,baptisiatinctoriaroot,bryoniaalbaroot,solanumdulcamaratop,echinaceaangustifolia,echinaceapurpurea,eupatoriumperfoliatumfloweringtop,ferrosoferricphosphate,gelsemiumsempervirensroot,potassiumchloride,phosphorus,anemonepulsatilla,sulfur,zincacetateanhydrous,zinccarbonate,zinc,zincchloride,zincoxide,zincpicratenonahyrdate,zincvaleratedihydrate,cairinamoschataheart/liverautolysate,influenzinum liquid
- NDC Code(s): 43406-0670-2
- Packager: Natural Creations, Inc.
- 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 19, 2022
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS (HPUS*): Arsenicum Album 10X, 30X, 100X, Baptisia Tinctoria 10X, 30X, 100X,Bryonia Alba 10X, 30X, 100X, Dulcamara 10X, 30X, 100X, Echinacea Angustifolia 10X, 30X, 100X, Echinacea Purpurea 10X, 30X, 100X, Eupatorium Perfoliatum 10X, 30X, 100X, Ferrum Phosphoricum 10X, 30X, 100X, Gelsemium Sempervirens 10X, 30X, 100X, Kali Muriaticum 10X, 30X, 100X, Phosphorus 10X, 30X, 100X, Pulsatilla 10X, 30X, 100X, Sulphur 10X, 30X, 100X, Zincum Aceticum 10X, 30X, 100X, Zincum Carbonicum 10X, 30X, 100X, Zincum Metallicum 10X, 30X, 100X, Zincum Muriaticum 10X, 30X, 100X, Zincum Oxydatum 10X, 30X, 100X, Zincum Picricum 10X, 30X, 100X, Zincum Val 10X, 30X, 100X, Anas Barbariae 50C, 100C, 200C, Influenzinum 50C, 100C, 200C.
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- Do not use if TAMPER EVIDENT seal is broken or missing.
- INACTIVE INGREDIENT
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD/FLU HP
arsenictrioxide,baptisiatinctoriaroot,bryoniaalbaroot,solanumdulcamaratop,echinaceaangustifolia,echinaceapurpurea,eupatoriumperfoliatumfloweringtop,ferrosoferricphosphate,gelsemiumsempervirensroot,potassiumchloride,phosphorus,anemonepulsatilla,sulfur,zincacetateanhydrous,zinccarbonate,zinc,zincchloride,zincoxide,zincpicratenonahyrdate,zincvaleratedihydrate,cairinamoschataheart/liverautolysate,influenzinum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0670 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 100 [hp_X] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 100 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 100 [hp_X] in 1 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 100 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 100 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 100 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 100 [hp_X] in 1 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 100 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 100 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 100 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 100 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 100 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 100 [hp_X] in 1 mL ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 [hp_X] in 1 mL ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37) ZINC CARBONATE 100 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 100 [hp_X] in 1 mL ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 [hp_X] in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 [hp_X] in 1 mL ZINC PICRATE NONAHYDRATE (UNII: 0057VRD75N) (ZINC CATION - UNII:13S1S8SF37) ZINC PICRATE NONAHYDRATE 100 [hp_X] in 1 mL ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 100 [hp_X] in 1 mL CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C] in 1 mL INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) WHOLE (UNII: FACIFOJ3Z7) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) WHOLE - UNII:FACIFOJ3Z7) INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) WHOLE 200 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0670-2 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2018 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc 030572478 manufacture(43406-0670)