Label: CALM- tribasic calcium phosphate,ferrosoferric phosphate,dibasic potassium phosphate,sodium phosphate, dibasic, heptahydrate and magnesium phosphate, dibasic trihydrate tablet

  • NDC Code(s): 54973-3331-1, 54973-3331-2
  • Packager: Hyland's
  • 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 21, 2017

If you are a consumer or patient please visit this version.

  • PURPOSE

    Natural relief of anxiousness, nervousness and irritability

  • Drug Facts

    Active Ingredients

    Purpose

    Calcarea Phosphorica 3X HPUS

    restlessness, anxiousness

    Ferrum Phosphoricum 3X HPUS

    nervousness

    Kali Phosphoricum 3X HPUS

    irritability, anxiousness, nervousness

    Natrum Phosphoricum 3X HPUS

    irritability, anxiousness and apprehensiveness

    Magnesia Phosphorica 3X HPUS

    anxiousness

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    Temporarily relieves the symptoms of restlessness, anxiousness, nervousness, and irritability.

  • WARNINGS

    As with any drug, ask doctor before use if pregnant or breast-feeding. Do not use • more than directed • if you have a known allergy to any ingredient in this product.

    Consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

    Do not use if imprinted tamper band is broken or missing.

    In case of emergency

    contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults & Children 12 years and over: dissolve 1-2 tablets under tongue 3 times per day. Sudden onset: every 15 minutes for up to 6 doses.

  • INACTIVE INGREDIENT

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON

    Non-habit forming

    NDC 54973-3331-1

    HOMEOPATHIC

    SINCE 1903

    Hyland's®

    Calm

    Natural relief of anxiousness,

    nervousness and irritability*

    50 QUICK-DISSOLVING TABLETS

    ACTUAL SIZE 194 MG

    Carton

  • INGREDIENTS AND APPEARANCE
    CALM 
    tribasic calcium phosphate,ferrosoferric phosphate,dibasic potassium phosphate,sodium phosphate, dibasic, heptahydrate and magnesium phosphate, dibasic trihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE3 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (Off White to Light Grey) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3331-11 in 1 CARTON12/04/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3331-24 in 1 POUCH; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/04/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3331) , pack(54973-3331) , label(54973-3331)