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 
Attuned Matrix, LLC

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.

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Drug Facts:

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:

For temporary relief of cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever.  For best results use at the first sign of a cold or flu.

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:

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

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:

For temporary relief of cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever. For best results use at the first sign of a cold or flu.

INACTIVE INGREDIENTS:

Ethanol 15%, Glycerin 15%, Purified Water.

QUESTIONS:

Manufactured for Attuned Matrix, LLC

893 Embarcadero Drive #102, El Dorado Hills, CA 95762

(916) 850-5152

PACKAGE LABEL DISPLAY:

Homeopathic

Cold & Flu Relief

2.0 Fluid OZ (60ml)

Cold & Flu Relief

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71144-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION8 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION8 [hp_X]  in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION8 [hp_X]  in 1 mL
POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE8 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED8 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP12 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA12 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP12 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71144-0001-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/19/2017
Labeler - Attuned Matrix, LLC (080469876)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(71144-0001) , api manufacture(71144-0001) , label(71144-0001) , pack(71144-0001)

Revised: 6/2017
Document Id: a98201e7-4e31-432f-92b0-327334a684e1
Set id: 8ed5792a-00d2-40b1-824b-488bde0bf2e0
Version: 2
Effective Time: 20170616
 
Attuned Matrix, LLC