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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Label Information

Updated November 23, 2016

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  • 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

    image description

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 29 mL
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA10 [hp_X]  in 29 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 29 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 29 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 29 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 29 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN10 [hp_X]  in 29 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 29 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 29 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 29 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 29 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 29 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT10 [hp_X]  in 29 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0049-129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/29/2014
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
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