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CALM N RESTFUL 4 KIDS (Hyland's)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (54973-3161-1) > 125 TABLET in 1 BOTTLE, PLASTIC Label Information

Complete CALM N RESTFUL 4 KIDS Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Aconitum Napellus 6X HPUS physical & mental restlessness
    Calcarea Phosphorica 12X HPUS peevishness
    Chamomilla 6X HPUS irritability, restlessness, occasional sleeplessness
    Cina 6X HPUS irritability of temper
    Lycopodium 6X HPUS lack of focus, extreme sensitivity
    Natrum Muriaticum 6X HPUS irritability, crying, oversensitivity
    Pulsatilla 6X HPUS occasional sleeplessness from travel
    Sulphur 6X HPUS irritability, 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 years dissolve 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 years dissolve 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 over dissolve 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3161
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 6 [hp_X]
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE 12 [hp_X]
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X]
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 5mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3161-1 1 in 1 CARTON 06/10/2013
    1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/10/2013
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3161)