Throat formula spray

Otc - active ingredient section

ACTIVE INGREDIENTS:Baptisia tinctoria 3X, Phytolacca decandra 3X, Apis mellifica 12X, Belladonna 12X, Lachesis mutus 12X, Mercurius solubilis 12X, Hepar sulphuris calcareum 15X.

Otc - purpose section

INDICATIONS:For relief of swollen tonsils, throat pain and burning of the throat.


Warnings section

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.

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 or administer to cildren under 3 years of age unless directed by phsician.

Dosage & administration section

DIRECTIONS:Spray orally 4-6 times daily. Consult a physician for use in children under 12 years of age.

Inactive ingredient section

INACTIVE INGREDIENTS:Demineralized water, 15% Ethanol, Herbal base Clove (flower), Golden seal (root) Myrrh (resin), Sage (leaf), Thyme (leaf), Menthol.


Otc - keep out of reach of children section

KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a Poison Control Center right away.


Indications & usage section

INDICATIONS:For relief of swollen tonsils, throat pain and burning of the throat.


Otc - questions section


Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935


For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935


Ingredients and appearance - Product information

Throat formula spray- Baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum,

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 57520-0294
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Baptisia tinctoria root ( UNII: 5EF0HWI5WU)( Baptisia tinctoria root - UNII: 5EF0HWI5WU ) 3 [hp_X]in 1 mL
Phytolacca americana root ( UNII: 11E6VI8VEG)( Phytolacca americana root - UNII: 11E6VI8VEG ) 3 [hp_X]in 1 mL
Apis mellifera ( UNII: 7S82P3R43Z)( Apis mellifera - UNII: 7S82P3R43Z ) 12 [hp_X]in 1 mL
Atropa belladonna ( UNII: WQZ3G9PF0H)( Atropa belladonna - UNII: WQZ3G9PF0H ) 12 [hp_X]in 1 mL
Lachesis muta venom ( UNII: VSW71SS07I)( Lachesis muta venom - UNII: VSW71SS07I ) 12 [hp_X]in 1 mL
Mercurius solubilis ( UNII: 324Y4038G2)( Mercurius solubilis - UNII: 324Y4038G2 ) 12 [hp_X]in 1 mL
Calcium sulfide ( UNII: 1MBW07J51Q)( Calcium sulfide - UNII: 1MBW07J51Q ) 15 [hp_X]in 1 mL

Inactive Ingredients

Ingredient Name Code
Clove ( UNII: K48IKT5321)
Goldenseal ( UNII: ZW3Z11D0JV)
Myrrh ( UNII: JC71GJ1F3L)
Sage ( UNII: 065C5D077J)
Thyme ( UNII: CW657OBU4N)
Water ( UNII: 059QF0KO0R)
Alcohol ( UNII: 3K9958V90M)
Glycerin ( UNII: PDC6A3C0OX)
Menthol ( UNII: L7T10EIP3A)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA

Labeler - Apotheca Company( 844330915)

Establishment

Name ID/FEI Business Operations
Apotheca Company 844330915 manufacture( 57520-0294), api manufacture( 57520-0294), label( 57520-0294), pack( 57520-0294)

Package label.principal display panel

BioActive Homeopathic

THROAT SPRAY FORMULA

2 FL OZ (60 ml)