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) TAB

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  • 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) TAB

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) TAB
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NDC 54973-3161-1
Set ID 8dae1ad1-14fa-4e4e-8c76-889ff1d0bee1
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

    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 symptoms of irritability or restlessness in children, including: occasional sleeplessness, physical or mental restlessness, peevishness, crying, oversensitivity, lack of focus

  • Uses

    ■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ physical or mental restlessness ■ peevishness ■ crying oversensitivity ■ lack of focus

  • Warnings

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

    Do not use more than directed.

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

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

    In case of emergency or accidental overdose, 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 years

    Dissolve 2 tablets under tongue every 15 minutes

    up to 8 doses, then every 4 hours until relieved.

    Children 6 years

    to under 12 years

    Dissolve 3 tablets under tongue every 15 minutes

    up to 8 doses, then every 4 hours until relieved.

    Adults and children

    12 years and over

    Dissolve 4 tablets under tongue every 15 minutes

    up to 8 doses, then every 4 hours until relieved.

  • Drug Facts (continued)

    Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

    ■ The inner packaged bottle is child-resistant.

  • Inactive ingredients

    Acacia Gum, Lactose

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    NDC 54973-3161-1


    2-12

    YEARS

    4 KIDS

    SINCE 1903
    Hyland's

    Calm &
    Restful*

    Relieves irritability, restlessness

    and occasional sleeplessness

    NO ARTIFICIAL FLAVORS

    NO DYES or PARABENS

    Natural
    Relief

    125 QUICK-DISSOLVING

    TABLETS

    *SEE NOTE ON SIDE

    PANEL BELOW DRUG FACTS

    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)
    Registrant - Standard Homeopathic Company (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3161)
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