BABY CALMING (MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, ANEMONE PULSATILLA, AND SULFUR) TABLET [HYLAND'S]

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  • BABY CALMING (MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, ANEMONE PULSATILLA, AND SULFUR) TABLET [HYLAND'S]

BABY CALMING (MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, ANEMONE PULSATILLA, AND SULFUR) TABLET [HYLAND'S]
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NDC 54973-3308-1, 54973-3308-2
Set ID 8f20251b-111b-4b7b-8098-4371d04004bd
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

    Drug Facts

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Chamomilla 6X HPUSoccasional sleeplessness, fussiness, and agitation
    Coffea Cruda 6X HPUSirritability
    Ignatia Amara 30X HPUS
    (less than 0.0000000000001% Alkaloids, calculated)     		restless sleep
    Lycopodium 30X HPUSunpredictable, irregular sleep
    Natrum Muriaticum 6X HPUScrying, irritability
    Platinum Metallicum 30X HPUScauseless crying, waking at night
    Pulsatilla 6X HPUScries easily, inconsolable
    Sulphur 12X HPUScrying, restlessness, irritability
  • Uses

    Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, irregular sleep; waking at night; crying; inconsolable behavior.

  • Warnings

    Consult a physician if:

    • symptoms persist for more than 72 hours or worsen
    • symptoms are accompanied by a fever

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

    In case of emergency

    contact a medical proffessional 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 under 6

    months of age

    consult a licensed health care professional

    before using this product

    children 6 months to

    under 1 year of age

    dissolve 2 tablets on tongue every 15 minutes

    for 4 doses, then hourly until relieved

    children 1 to under 3

    years of age

    dissolve 3 tablets on tongue every 15 minutes

    for 4 doses, then hourly until relieved

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

    NDC 54973-3308-1
    HOMEOPATHIC

    Ages
    6 months+

    SINCE 1903
    Hyland's®
    Baby

    Natural
    Relief

    Calming
    Tablets

    NATURAL RELIEF OF
    OCCASIONAL SLEEPLESSNESS,
    FUSSINESS, AND IRRITABILITY*

    ‣ No Artificial Flavors, Dyes or Parabens

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING TABLETS

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY CALMING 
    matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3308
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM30 [hp_X]
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3308-11 in 1 CARTON01/20/2017
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3308-26 in 1 PACKET; Type 0: Not a Combination Product01/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3308) , pack(54973-3308) , label(54973-3308)
    Establishment
    NameAddressID/FEIBusiness Operations
    MeriCal, Inc.029644978manufacture(54973-3308)
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