GALLIC ACID- gallicum acidum liquid
BioActive Nutritional

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:

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)

image description

GALLIC ACID
gallicum acidum liquid

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0234-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/23/2013	07/24/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/23/2013	07/24/2023

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

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

Revised: 6/2023

Document Id: c88df17e-ad49-4675-bc50-88db5a789e21

Set id: a80f60b1-1e1b-432b-bb89-d7ada1d0b811

Version: 2

Effective Time: 20230608

BioActive Nutritional