GALLIC ACID- gallicum acidum liquid

Gallic Acid by

Drug Labeling and Warnings

Gallic Acid by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Gallicum Acidum 6X, 12X, 30X, 12C, 30C

INDICATIONS:

For temporary relief of allergic rhinitis, general fatigue, nasal congestion, joint pain, lower back pain, headaches, dyspepsia, and itching.

WARNINGS:

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

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

DIRECTTIONS:

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

INDICATIONS:

For temporary relief of allergic rhinitis, general fatigue, nasal congestion, joint pain, lower back pain, headaches, dyspepsia, and itching.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE DISPLAY LABEL:

​BioActive Homeopathic

GALLIC ACID

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

GALLIC ACID 
gallicum acidum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GALLIC ACID MONOHYDRATE (UNII: 48339473OT) (GALLIC ACID - UNII:632XD903SP)	GALLIC ACID MONOHYDRATE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0234-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/23/2013

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0234) , api manufacture(43857-0234) , label(43857-0234) , pack(43857-0234)