Gallic Acid: Homeopathic Product Information

GALLIC ACID- gallic acid monohydrate 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.

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)

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GALLIC ACID
gallicum acidum liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0234
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALLIC ACID MONOHYDRATE (GALLIC ACID) GALLIC ACID MONOHYDRATE 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43857-0234-1 30 mL in 1 BOTTLE, DROPPER None
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 Operations
Apotheca Company 844330915 manufacture (43857-0234), api manufacture (43857-0234), label (43857-0234), pack (43857-0234)

Revised: 09/2013 BioActive Nutritional

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