FIBROCANE CALM- aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona o

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

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Active ingredient:
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD), AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M), ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV), AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F), ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), CINCHONA OFFI
Available from:
Premier Bioceuticals LLC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep. FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: - restlessness - nervousness - exhaustion - excitability - worry or inability to fall or stay asleep
Authorization status:
unapproved homeopathic
Authorization number:
57850-0001-1

FIBROCANE CALM- aconitum napellus, aesculus hippocastanum, flos, arsenicum album,

avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens,

hyoscyamus niger, ignatia amara, passiflora incarnata, pulsatilla, valeriana officinalis liquid

Premier Bioceuticals LLC.

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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FibroCane CALM

Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:

restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.

Active Ingredients: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa,

Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus

niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each

ingredient at 10X, 30X, LM1 potencies.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Directions: Initially, depress pump until primed. Hold close and spray directly into your mouth. Take 2

pump sprays twice daily, morning and evening. Additional sprays may be taken during the night as

needed. For ages 12 and above.

Warnings

Stop use and call a doctor if symptoms persist or worsen.

If pregnant or breast-feeding, consult a healthcare professional before use.

Keep out of reach of children.

Other Information:

Tamper resistant for your protection. Use only if safety seal is intact.

FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:

restlessness

nervousness

exhaustion

excitability

worry or inability to fall or stay asleep

FIBROCANE CALM

aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona

officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, passiflora incarnata, pulsatilla,

valeriana officinalis liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:578 50 -0 0 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:U0 NQ8 555JD)

ACONITUM NAPELLUS

10 [hp_X]

in 29 .6 mL

AESCULUS HIPPO CASTANUM FLO WER (UNII: KK0 Z9 2II8 M) (AESCULUS

HIPPOCASTANUM FLOWER - UNII:KK0 Z9 2II8 M)

AESCULUS

HIPPOCASTANUM FLOWER

10 [hp_X]

in 29 .6 mL

ARSENIC TRIO XIDE (UNII: S7V9 2P6 7HO) (ARSENIC CATION (3+) -

UNII:C9 6 6 13F5AV)

ARSENIC TRIOXIDE

10 [hp_X]

in 29 .6 mL

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

FLOWERING TOP - UNII:MA9 CQJ3F7F)

AVENA SATIVA

FLOWERING TOP

10 [hp_X]

in 29 .6 mL

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

10 [hp_X]

in 29 .6 mL

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) -

UNII:N20 HL7Q9 41)

CAMPHOR (NATURAL)

10 [hp_X]

in 29 .6 mL

CINCHO NA O FFICINALIS BARK (UNII: S0 0 3A158 SB) (CINCHONA OFFICINALIS

BARK - UNII:S0 0 3A158 SB)

CINCHONA OFFICINALIS

BARK

10 [hp_X]

in 29 .6 mL

ARABICA CO FFEE BEAN (UNII: 3SW6 78 MX72) (ARABICA COFFEE BEAN -

UNII:3SW6 78 MX72)

ARABICA COFFEE BEAN

10 [hp_X]

in 29 .6 mL

CYPRIPEDIUM PARVIFO LUM RO O T (UNII: 21Y9 GZ1LZA) (CYPRIPEDIUM

PARVIFOLUM ROOT - UNII:21Y9 GZ1LZA)

CYPRIPEDIUM PARVIFOLUM

ROOT

10 [hp_X]

in 29 .6 mL

HYO SCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER -

UNII:4WRK2153H3)

HYOSCYAMUS NIGER

10 [hp_X]

in 29 .6 mL

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

UNII:1NM3M248 7K)

STRYCHNOS IGNATII SEED

10 [hp_X]

in 29 .6 mL

PASSIFLO RA INCARNATA FLO WERING TO P (UNII: CLF5YFS11O) (PASSIFLORA

PASSIFLORA INCARNATA

10 [hp_X]

Premier Bioceuticals LLC.

INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)

FLOWERING TOP

in 29 .6 mL

PULSATILLA VULGARIS (UNII: I76 KB35JEV) (PULSATILLA VULGARIS -

UNII:I76 KB35JEV)

PULSATILLA VULGARIS

10 [hp_X]

in 29 .6 mL

VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)

VALERIAN

10 [hp_X]

in 29 .6 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:578 50 -0 0 0 1-1

29 .6 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

10 /31/20 13

Labeler -

Premier Bioceuticals LLC. (027714978)

Registrant -

Premier Bioceuticals LLC. (027714978)

Revised: 6/2014

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