CALM- aconitum napellus, alfalfa, argentum nitricum, avena sativa, chamomilla, gelsemium sempervirens, glonoinum, histaminum hydrochloricum, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, veratrum album liquid

Calm by

Drug Labeling and Warnings

Calm by is a Homeopathic medication manufactured, distributed, or labeled by New Sun Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

WARNINGS

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

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

Indications: For temporary relief of: stress induced states such as: nervous tension minor anxieties fearfulness over-sensitivity

ACTIVE INGREDIENT

Active Ingredients: ​Aconitum napellus, Alfalfa, Argentum nitricum, Avena sativa, Chamomilla, Gelsemium sempervirens, Glonoinum, Histaminum hydrochloricum, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Veratrum album. ​Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

INACTIVE INGREDIENT

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

INDICATIONS & USAGE

Indications: For temporary relief of: stress induced states such as:

• nervous tension
• minor anxiety
• fearfulness
• over-sensitivity

For promoting:

• calm
• confidence

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALM 
aconitum napellus, alfalfa, argentum nitricum, avena sativa, chamomilla, gelsemium sempervirens, glonoinum, histaminum hydrochloricum, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, veratrum album liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66579-0049
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 mL
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	10 [hp_X]  in 29 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X]  in 29 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 29 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 29 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X]  in 29 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	10 [hp_X]  in 29 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	10 [hp_X]  in 29 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X]  in 29 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	10 [hp_X]  in 29 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 29 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 29 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	10 [hp_X]  in 29 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66579-0049-1	29 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/29/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/29/2014

Labeler - New Sun Inc. (957251176)

Registrant - New Sun Inc. (957251176)