INFLAMMATION I- echinacea angustifolia, hydrastis canadensis, nasturtium aquaticuechinacea angustifolia, hydrastis canadensis, nasturtium aquaticum, phytolacca decandra, apis mellifica, belladonna, ferrum phosphoricum, nitricum acidum, oleander, silicea, phytolacca decandra, apis mellifica, belladonna, ferrum phosphoricum, nitricum acidum, oleander,silicea liquid 
Apotheca Company

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, Hydrastis Canadensis 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.

Indications:  For temporary relief of swollen throat, minor throbbing pain deep in the ear;  joints swollen and hot;  chills and fever with nausea.

WARNINGS:  If pregnant or breast-feeding, ask a health care professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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

Directions:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

Warning:   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 two days of administer to children under 3 years of age unless directed by physician.

INDICATIONS & USAGE SECTION:

For temporary relief of swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

Inactive Ingredients:  Demineralized Water, 25% Ethanol


Distributed By:

BioActive Nutritional

Melbourne, FL 32935


For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935


PACKAGE LABEL DISPLAY:

BioActive Homeopathic

INFLAMMATION I

1FL OZ (30 ml)

Inflammation I

INFLAMMATION  I
echinacea angustifolia, hydrastis canadensis, nasturtium aquaticuechinacea angustifolia, hydrastis canadensis, nasturtium aquaticum, phytolacca decandra, apis mellifica, belladonna, ferrum phosphoricum, nitricum acidum, oleander, silicea, phytolacca decandra, apis mellifica, belladonna, ferrum phosphoricum, nitricum acidum, oleander,silicea liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0148
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 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676) (RORIPPA NASTURTIUM-AQUATICUM - UNII:YH89GMV676) RORIPPA NASTURTIUM-AQUATICUM3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID12 [hp_X]  in 1 mL
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0148-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/09/201010/19/2016
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0148) , api manufacture(57520-0148) , label(57520-0148) , pack(57520-0148)

Revised: 8/2015
 
Apotheca Company