WELLNESS COLD AND FLU (echinacea (angustifolia), allium cepa, bryonia- alba, gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2015-2016, tablet, chewable

Wellness Cold and Flu by

Drug Labeling and Warnings

Wellness Cold and Flu by is a Homeopathic medication manufactured, distributed, or labeled by Source Naturals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Echinacea (Angustifolia) 3X, Allium Cepa 4X, Bryonia (Alba) 4X, Gelsemium Sempervirens 4X, Sanguinaria Canadensis 4X, Eupatorium Perfoliatum 6X, Kali Bichromicum 6X, Phosphorus 6X, Aconitum Napellus 12, Influenzinum 2015-2016 12X.

INDICATIONS:

For the temporary relief of cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms.  Effective at all stages of cold and flu.

WARNINGS:

In case of overdose, get medical help or contact a Poison Control Center right away.

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a physician promptly.

Do not use more than 2 days or administer to children under 2 years of age unless directed by a physician.  

A persistent cough or high fever may be the sign of a serious health condition. If fever persists for more than 3 days, consult a physician.

If cough persists for more than one week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a physician

Do not take this product for consistent or chronic cough such as occurs with smoking, asthma, or emphysema, or is cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a health care professional before using this product.

Keep this and all medicines out of the reach of children.

Tamper Evident:  Do not use if foil blister backing is broken.  Foil backing is printed with product name and lot number.

STORE IN A COOL, DRY PLACE.

KEEP OUT OF REACH OF CHILDREN:

Keep this and all medicines out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Chew 1 tablet slightly and allow to dissolve in the mouth.  Adults and children over age 12 take 1 every 2 to 4 hours until symptoms improve, then take as needed.  For optimal results, take 3-6 doses per day.

Children ages 2 to 12 years, use one half the adult dosage.  

For children under the age of 2 years, consult your health care professional.

For Best Results: Keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. These substances may interfere with sublingual absorption.

INDICATIONS:

For the temporary relief of cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms. Effective at all stages of cold and flu.

INACTIVE INGREDIENTS:

Lactose, Magnesium Stearate And Echinacea Angustifolia Root Extract.

QUESTIONS:

Source Naturals, Inc.
P.O. Box 2118
Santa Cruz, Ca. USA 95062
www.sourcenaturals.com

PACKAGE LABEL DISPLAY:

SOURCE NATURALS

with homeopathic                                                 safe & effective

echinacea                                                             formula

BIO

 ALIGN

Wellness

Cold & Flu

Relieves Symptoms: Fever Sore Throat  Sneezing  Body Aches  Chest Congestion

48 HOMEOPATHIC TABLETS

INGREDIENTS AND APPEARANCE

WELLNESS COLD AND FLU 
echinacea (angustifolia), allium cepa, bryonia (alba), gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2015-2016, tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64471-164
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	4 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: KFL1W6W9JB) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:KFL1W6W9JB)	INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 80T3QS071U) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:80T3QS071U)	INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]
INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: V3EC8AF8MF) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:V3EC8AF8MF)	INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]
INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 445486QJCG) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:445486QJCG)	INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]
INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 9VVQ21KI5Z) (INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z)	INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]
INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 3W5C8YUT4D) (INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:3W5C8YUT4D)	INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (TABLET)	Size	10mm
Flavor		Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64471-164-48	2 in 1 CARTON	11/17/2016
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/15/2016

Labeler - Source Naturals, Inc. (969024228)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(64471-164) , api manufacture(64471-164) , label(64471-164) , pack(64471-164)