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NDC 71144-0001-01 Cold and Flu Relief 12; 12; 3; 6; 12; 12; 8; 12; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Cold and Flu Relief 12; 12; 3; 6; 12; 12; 8; 12; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Cold and Flu Relief is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Attuned Matrix, LLC. The primary component is ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CALCIUM SULFATE ANHYDROUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHL.

Product Information

NDC	71144-0001
Product ID	71144-0001_a98201e7-4e31-432f-92b0-327334a684e1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cold and Flu Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	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, Eupatoriu
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	12; 12; 3; 6; 12; 12; 8; 12; 8; 8; 8; 8; 8; 12; 8; 8
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CALCIUM SULFATE ANHYDROUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHL
Labeler Name	Attuned Matrix, LLC
Pharmaceutical Class	Allergens [CS], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Inc
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71144-0001-01 (71144000101)

Pricing Information	N/A
NDC Package Code	71144-0001-1
Billing NDC	71144000101
Package	60 mL in 1 BOTTLE, SPRAY (71144-0001-1)
Marketing Start Date	2017-01-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8ed5792a-00d2-40b1-824b-488bde0bf2e0 Details

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)

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 spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71144-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71144-0001-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/19/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/19/2017

Labeler - Attuned Matrix, LLC (080469876)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(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

Search by Drug Name or NDC

NDC 71144-0001-01 Cold and Flu Relief 12; 12; 3; 6; 12; 12; 8; 12; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Cold and Flu Relief 12; 12; 3; 6; 12; 12; 8; 12; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 71144-0001-01 (71144000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8ed5792a-00d2-40b1-824b-488bde0bf2e0 Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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