MIRACET- abies nigra, aconitum napellus, arsenicum iodatum, avena sativa, ignatia amara, lung suis, nux vomica, plantago major,

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

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Active ingredient:
PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131), ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD), ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV), AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F), STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K), SUS SCROFA LUNG (UNII: 7GL3G1COB3) (SUS SCROFA LUNG - UNII:7GL3G1COB3), STRYCHNOS NUX-VOMICA SEED
Available from:
Pacific Naturals
Administration route:
oral
Prescription type:
OTC DRUG
Therapeutic indications:
Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite. Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness, insomnia, cough, and increased appetite.
Authorization status:
unapproved homeopathic
Authorization number:
43695-0004-1

MIRACET- abies nigra, aconitum napellus, arsenicum iodatum, avena sativa, ignatia amara,

lung suis, nux vomica, plantago major, quebracho liquid

Pacific Naturals

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 INGREDIENTS:

Abies Nigra 10X, Aconitum Napellus 200C, Arsenicum Iodatum 200C, Avena Sativa 1X, Ignatia Amara

200C, Lung Suis 6X, Nux Vomica 10X, Plantago Major 3X, Quebracho 3X, Stricta Pulmonaria 200C,

Tabacum 200C.

INDICATIONS:

Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness,

insomnia, cough, and increased appetite.

WARNINGS:

If you are pregnant or breast feeding,

seek the advice of a doctor 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 imprinted tamper evident seal around neck of bottle is missing or broken.

DIRECTIONS:

Adults and Children over 12: Spray twice under the tongue 3 times per day.

For Children under 12:

Consult a doctor prior to use.

INACTIVE INGREDIENTS:

Alcohol 20% v/v, Purified water.

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.

INDICATIONS:

Relieves symptoms associated with nicotine withdrawal, such as: craving for cigarettes, nervousness,

insomnia, cough, and increased appetite.

QUESTIONS:

Distributed By:

Nutrology

2049 North Lincoln Street

Burbank, CA 91504

PACKAGE DISPLAY LABEL:

MIRACET

Nicotine Craving Relief

HOMEOPATHIC

1.0 fl. oz. (30 mL), 20% alcohol

MIRACET

abies nigra, aconitum napellus, arsenicum iodatum, avena sativa, ignatia amara, lung suis, nux vomica, plantago

major, quebracho liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:436 9 5-0 0 0 4

Route of Administration

o ra l

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PICEA MARIANA RESIN (UNII: 71AOV0 W131) (PICEA MARIANA RESIN -

UNII:71AOV0 W131)

PICEA MARIANA RESIN

10 [hp_X]

in 1 mL

ACO NITUM NAPELLUS (UNII: U0 NQ8 555JD) (ACONITUM NAPELLUS -

UNII:U0 NQ8 555JD)

ACONITUM NAPELLUS

20 0 [hp_C]

in 1 mL

ARSENIC TRIIO DIDE (UNII: 30 29 9 8 8 O2T) (ARSENIC CATION (3+) -

UNII:C9 6 6 13F5AV)

ARSENIC TRIIODIDE

20 0 [hp_C]

in 1 mL

AVENA SATIVA FLO WERING TO P (UNII: MA9 CQJ3F7F) (AVENA SATIVA

FLOWERING TOP - UNII:MA9 CQJ3F7F)

AVENA SATIVA FLOWERING

1 [hp_X]

in 1 mL

STRYCHNO S IGNATII SEED (UNII: 1NM3M248 7K) (STRYCHNOS IGNATII SEED -

UNII:1NM3M248 7K)

STRYCHNOS IGNATII SEED

20 0 [hp_C]

in 1 mL

6 [hp_X]

Pacific Naturals

SUS SCRO FA LUNG (UNII: 7GL3G1COB3) (SUS SCROFA LUNG - UNII:7GL3G1COB3)

SUS SCROFA LUNG

6 [hp_X]

in 1 mL

STRYCHNO S NUX-VO MICA SEED (UNII: 26 9 XH139 19 ) (STRYCHNOS NUX-VOMICA

SEED - UNII:26 9 XH139 19 )

STRYCHNOS NUX-VOMICA

SEED

10 [hp_X]

in 1 mL

PLANTAGO MAJO R (UNII: W246 9 WNO6 U) (PLANTAGO MAJOR -

UNII:W246 9 WNO6 U)

PLANTAGO MAJOR

3 [hp_X]

in 1 mL

ASPIDO SPERMA Q UEBRACHO -BLANCO BARK (UNII: 52B1340 19 0 )

(ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340 19 0 )

ASPIDOSPERMA

QUEBRACHO-BLANCO

BARK

3 [hp_X]

in 1 mL

LO BARIA PULMO NARIA (UNII: D1YM0 P5Z2T) (LOBARIA PULMONARIA -

UNII:D1YM0 P5Z2T)

LOBARIA PULMONARIA

20 0 [hp_C]

in 1 mL

TO BACCO LEAF (UNII: 6 YR26 0 8 RSU) (TOBACCO LEAF - UNII:6 YR26 0 8 RSU)

TOBACCO LEAF

20 0 [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)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:436 9 5-0 0 0 4-1

30 mL in 1 BOTTLE, SPRAY

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 8 /0 1/20 13

Labeler -

Pacific Naturals (184784283)

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(436 9 5-0 0 0 4) , api manufacture(436 9 5-0 0 0 4) , label(436 9 5-0 0 0 4) ,

pa c k(436 9 5-0 0 0 4)

Revised: 8/2013

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