Label: WELLNESS DEFENSE (echinacea (angustifolia), allium cepa, bryonia- alba, gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2017-2018 tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 64471-416-48 - Packager: Source Naturals, Inc.
- 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 July 23, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- INDICATIONS:
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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.
Contains milk.
- KEEP OUT OF REACH OF CHILDREN:
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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:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
WELLNESS DEFENSE
echinacea (angustifolia), allium cepa, bryonia (alba), gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2017-2018 tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64471-416 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/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 9JWN7VDQ7N) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:U6C4GJ6WZG) INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 12 [hp_X] INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3DZY3Q314E) (INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:C2C4DA5K06) INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) 12 [hp_X] INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 293LSV29OL) (INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:45E2IPU4MG) INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 12 [hp_X] Inactive Ingredients Ingredient Name Strength ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64471-416-48 2 in 1 CARTON 07/23/2018 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 07/23/2018 Labeler - Source Naturals, Inc. (969024228) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(64471-416) , api manufacture(64471-416) , label(64471-416) , pack(64471-416)
