Label: BABY CALMING- matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tablet

  • NDC Code(s): 54973-3308-1, 54973-3308-2
  • Packager: Hyland's
  • Category: HUMAN OTC DRUG LABEL

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 20, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 symptoms of irritability or restlessness in children, including:

    ■ occasional sleeplessness ■ fussiness ■ agitation
    ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night
    ■ crying ■ inconsolable behavior

  • Warnings

    Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen.

    ■ symptoms are accompanied by a fever.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.

    Children under 6 monthsAsk a doctor before use.
    Children 6 months
    to under 1 year
    At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
    Children 1 year
    to under 3 years
    At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    www.hylands.com or (800) 624-9659

  • SPL UNCLASSIFIED SECTION

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

  • OTHER SAFETY INFORMATION

    DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Hyland's

    Naturals™

    •baby•

    Calming

    Tablets*

    NO ARTIFICIAL FLAVORS,

    DYES or PARABENS

    Sleeplessness

    Fussiness

    Irritability

    6+ MONTHS

    125

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    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 Product01/20/201712/20/2021
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3308) , pack(54973-3308) , label(54973-3308)