NDC | 64471-164-48 |
Set ID | c92d5972-38e7-4dde-a748-737daca49aba |
Category | HUMAN OTC DRUG LABEL |
Packager | Source Naturals, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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.
- 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 COLD AND FLU
echinacea (angustifolia), allium cepa, bryonia (alba), gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2015-2016, tablet, chewableProduct 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)