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

FibroCane CALM by

Drug Labeling and Warnings

FibroCane CALM by is a Homeopathic medication manufactured, distributed, or labeled by Premier Bioceuticals LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.

ACTIVE INGREDIENT

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 INGREDIENT

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

DOSAGE & ADMINISTRATION

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

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

• Keep out of reach of children.

OTHER SAFETY INFORMATION

Other Information:

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

PURPOSE

FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:

• restlessness
• nervousness
• exhaustion
• excitability
• worry or inability to fall or stay asleep

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57850-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]  in 29.6 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	10 [hp_X]  in 29.6 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 29.6 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 29.6 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 29.6 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	10 [hp_X]  in 29.6 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]  in 29.6 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X]  in 29.6 mL
CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFOLUM ROOT	10 [hp_X]  in 29.6 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	10 [hp_X]  in 29.6 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X]  in 29.6 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 29.6 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	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	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57850-0001-1	29.6 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/31/2013

Labeler - Premier Bioceuticals LLC. (027714978)

Registrant - Premier Bioceuticals LLC. (027714978)