Label: COLD AND FLU RELIEF- baptisia tinctoria, calcarea sulphurica, allium cepa, calcarea carbonica, calcarea phosphorica, ferrum phosphoricum, kali muriaticum, kali sulphuricum, silicea, spongia tosta, aconitum napellus, arsenicum album, dulcamara, euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens spray
- NDC Code(s): 71144-0001-1
- Packager: Attuned Matrix, LLC
- 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 June 16, 2017
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ACTIVE INGREDIENTS:
Baptisia Tinctoria 3X, Calcarea Sulphurica 6X, Allium Cepa 8X, Calcarea Carbonica 8X, Calcarea Phosphorica 8X, Ferrum Phosphoricum 8X, Kali Muriaticum 8X, Kali Sulphuricum 8X, Silicea 8X, Spongia Tosta 8X, Aconitum Napellus 12X, Arsenicum Album 12X, Dulcamara 12X, Euphrasia Officinalis 12X, Eupatorium Perfoliatum 12X, Gelsemium Sempervirens 12X
- INDICATIONS:
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WARNINGS:
Do NOT use if you have ever had an allergic reaction to this product or any of its ingredients.
Stop use and ask a doctor if your symptoms persist, worsen or new symptoms occur.
Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
If pregnant or breast feeding, ask a doctor before using product.
Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken
Store at room temperature and keep out of direct sunlight.
- KEEP OUT OF REACH OF CHILDREN:
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DIRECTIONS:
Adults & children over 12 years: Spray twice under the tongue three times per day until symptoms are gone.
Children 12 years and under: Consult a Doctor prior to use.
Sore Throat Warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
COLD AND FLU RELIEF
baptisia tinctoria, calcarea sulphurica, allium cepa, calcarea carbonica, calcarea phosphorica, ferrum phosphoricum, kali muriaticum, kali sulphuricum, silicea, spongia tosta, aconitum napellus, arsenicum album, dulcamara, euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71144-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 8 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 8 [hp_X] in 1 mL FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 8 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 8 [hp_X] in 1 mL POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE 8 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 8 [hp_X] in 1 mL ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 12 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 12 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 12 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 12 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71144-0001-1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/19/2017 Labeler - Attuned Matrix, LLC (080469876) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(71144-0001) , api manufacture(71144-0001) , label(71144-0001) , pack(71144-0001)
