ASPERGILLUS NIGER- aspergillus niger liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6)
Available from:
Energique, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
To be used according to standard homeopathic indications.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. To be used according to standard homeopathic indications.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
44911-0173-1

ASPERGILLUS NIGER- aspergillus niger liquid

Energique, Inc.

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.

----------

DRUG FACTS:

ACTIVE INGREDIENT:

Aspergillus Niger 30C.

INDICATIONS:

To be used according to standard homeopathic indications.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

WARNINGS:

If pregnant or breast-feeding, ask a health 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:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care

professional. If symptoms persist, consult your health care professional. Consult a physician for use in

children under 12 years of age.

INDICATIONS:

To be used according to standard homeopathic indications.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

ASPERGILLUS

NIGER 30C

1 fl. oz. (30 ml)

ASPERGILLUS NIGER

aspergillus niger liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:449 11-0 173

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPERGILLUS NIGER VAR. NIGER (UNII: 9 IOA40 ANG6 ) (ASPERGILLUS NIGER VAR.

NIGER - UNII:9 IOA40 ANG6 )

ASPERGILLUS NIGER

VAR. NIGER

30 [hp_C]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Energique, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:449 11-

0 173-1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 7/0 7/20 15

Labeler -

Energique, Inc. (789886132)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(449 11-0 173) , api manufacture(449 11-0 173) , label(449 11-0 173) , pack(449 11-

0 173)

Revised: 7/2015

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