DRUG FACTS:

Drug Labeling and Warnings

Drug Details [pdf]

WELLNESS COLD AND FLU- echinacea (angustifolia), allium cepa, bryonia (alba), eupatorium perfoliatum, gelsemium sempervirens, sanguinaria canadensis, kali bichromicum, phosphorus, aconitum napellus, influenzinum tablet 
Source Naturals, Inc.

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:

Echinacea (Angustifolia) 3X, Allium Cepa 4X, Bryonia (Alba) 4X, Eupatorium Perfoliatum 4X, Gelsemium Sempervirens 4X, Sanguinaria Canadensis 4X, Kali Bichromicum 6X, Phosphorus 6X, Aconitum Napellus 12X, Influenzinum 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 3 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, of if cough is accompanied my 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

Contains milk.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Chew 1 tablet slightly and allow to dissolve in the mouth. Adults 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:

Echinacea Angustifolia Root Extract, Lactose and Magnesium Stearate

QUESTIONS:

Distributed by:

SOURCE NATURALS, INC.

P.O. BOX 2118, SANTA CRUZ, CA. USA 95062

www.sourcenaturals.com

PACKAGE LABEL DISPLAY:

SOURCE NATURALS

NDC: 64471-054-48

with homeopathic                             safe & effective
echinacea                                        formula

BIO
ALIGN

Wellness
Cold & Flu

Fever Sore Throat Sneezing Body Aches Chest Congestion

48 HOMEOPATHIC TABLETS

Wellness Cold and Flu         front

Wellness Cold and Flu             back

WELLNESS COLD AND FLU 
echinacea (angustifolia), allium cepa, bryonia (alba), eupatorium perfoliatum, gelsemium sempervirens, sanguinaria canadensis, kali bichromicum, phosphorus, aconitum napellus, influenzinum tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64471-054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mg
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION4 [hp_X]  in 1 mg
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 1 mg
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP4 [hp_X]  in 1 mg
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 1 mg
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 1 mg
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]  in 1 mg
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 1 mg
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mg
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XQO8062U6R) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:C8E791RO82) INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)12 [hp_X]  in 1 mg
INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN (UNII: 0KB5E5H415) (INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN - UNII:0KB5E5H415) INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN12 [hp_X]  in 1 mg
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: W45Z4CJE2J) (INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:166D8OWM7B) INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)12 [hp_X]  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64471-054-4814400 mg in 1 BLISTER PACK; Type 0: Not a Combination Product06/08/201508/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/08/201508/05/2019
Labeler - Source Naturals, Inc. (969024228)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(64471-054) , api manufacture(64471-054) , label(64471-054) , pack(64471-054)

Revised: 2/2017
 

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