Label: COLD- baptisia tinctoria, echinacea angustifolia, eupatorium perfoliatum, lomatium dissectum, pueraria lobata, trifolium pratense, phytolacca decandra, allium cepa, arsenicum iodatum, baryta carbonica, bromium, calcarea carbonica, kali muriaticum, lachesis mutus, mercurius solubilis, silicea liquid
- NDC Code(s): 43406-0688-1
- 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 21, 2018
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X
- INDICATIONS & USAGE
- PURPOSE
- 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 care 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.
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- 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
baptisia tinctoria, echinacea angustifolia, eupatorium perfoliatum, lomatium dissectum, pueraria lobata, trifolium pratense, phytolacca decandra, allium cepa, arsenicum iodatum, baryta carbonica, bromium, calcarea carbonica, kali muriaticum, lachesis mutus, mercurius solubilis, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0688 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BAPTISIA TINCTORIA WHOLE (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA WHOLE 4 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 4 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 4 [hp_X] in 1 mL LOMATIUM DISSECTUM ROOT (UNII: 5329928G5N) (LOMATIUM DISSECTUM ROOT - UNII:5329928G5N) LOMATIUM DISSECTUM ROOT 4 [hp_X] in 1 mL PUERARIA MONTANA VAR. LOBATA WHOLE (UNII: D295OFK7E1) (PUERARIA MONTANA VAR. LOBATA WHOLE - UNII:D295OFK7E1) PUERARIA MONTANA VAR. LOBATA WHOLE 4 [hp_X] in 1 mL TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 4 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 1 mL ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE 12 [hp_X] in 1 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 12 [hp_X] in 1 mL BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 12 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 12 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 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:43406-0688-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/07/2019 Labeler - Natural Creations, Inc (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc 030572478 manufacture(43406-0688)
