Label: CALM N RESTFUL 4 KIDS- aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet

  • 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 December 9, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Aconitum Napellus 6X HPUSphysical & mental restlessness
    Calcarea Phosphorica 12X HPUSpeevishness
    Chamomilla 6X HPUSirritability, restlessness, occasional sleeplessness
    Cina 6X HPUSirritability of temper
    Lycopodium 6X HPUSlack of focus, extreme sensitivity
    Natrum Muriaticum 6X HPUSirritability, crying, oversensitivity
    Pulsatilla 6X HPUSoccasional sleeplessness from travel
    Sulphur 6X HPUSirritability, peevishness

    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • PURPOSE

    Temporarily relieves the symptoms of occasional sleeplessness, mental and physical restlessness, irritability, and occasional sleeplessness due to travel and lack of focus in children.

  • Uses

    Temporarily relieves the symptoms of occasional sleeplessness, mental and physical restlessness, irritability, and occasional sleeplessness due to travel and lack of focus in children.

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Consult a physician if:

    • Symptoms persist for more than 7 days or worsen
    • Child is taking any prescription medicines

    Keep this and all medications out of the reach of children.

    In case of accidental overdose, contact a medical professional or a 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

    Children 2 years to under 6 yearsdissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Children 6 years to under 12 yearsdissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Adults and children 12 years and overdissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
  • Inactive ingredients

    Acacia Gum, Lactose

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

    Natural
    Relief

    NDC 54973-3161-1
    HOMEOPATHIC

    Ages
    2-12

    SINCE 1903
    Hyland's®

    4 Kids

    Calm 'n
    Restful*

    Occasional Sleeplessness

    Mental & Physical Restlessness

    Irritability

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING TABLETS

    SAFE &
    EFFECTIVE

    carton

  • INGREDIENTS AND APPEARANCE
    CALM N RESTFUL 4 KIDS 
    aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT6 [hp_X]
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE12 [hp_X]
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP6 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3161-11 in 1 CARTON06/10/2013
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/10/2013
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3161)