Label: BABY COLIC RELIEF- aethusa cynapium, aloe, carbo vegetabilis, chamomilla, colocynthis, mentha piperita, pulsatilla, senna, silicea, valeriana officinalis, zingiber officinale liquid

  • 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 March 2, 2018

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

  • HPUS Active Ingredients

    Aethusa cynapium, Aloe, Carbo vegetabilis, Chamomilla, Colocynthis, Mentha piperita, Pulsatilla, Senna, Silicea, Valeriana officinalis, Zingiber officinale

  • Inactive Ingredients

    Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

  • Directions

    • Initially, depress pump until primed
    • Spray one dose directly into mouth

    Under 6 Months: Consult a licensed healthcare professional before using

    6 months to 2 years: 1 spray every 15 minutes, up to 4 doses, then hourly until relieved

    2 years and older: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

  • Purpose

    Aethusa cynapium.............restlessness, irritability

    Aloe................................gas reief, bloating, colic before & after stool

    Carbo vegetabilis..............gas with colic, upset stomach

    Chamomilla......................irritability, ooversensitivity

    Colocynthis......................abdominal discomfort

    Mentha piperita.................infantile colic, accumulation of gas

    Pulsatilla...........................stomach cramps, desire to be held

    Senna..............................colic, gas, constipation

    Silicea..............................belching, colic

    Valeriana officinalis.............irritability, bloating, sleeplessness

    Zingiber officinale................digestive aid, colic pain, flatulence

  • Warnings

    Stop use and ask a doctor, if symptoms persist or worsen

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Other Information

    This product is intended to compliment, not replace, standard medical care.

    Tamper resistant for your protection. Use only if safety seal is intact.

  • Uses

    for temporary relief of symptoms:

    • abdominal discomfort
    • pressure and distention
    • spitting up
    • gas and bloating
    • cramping
    • pain
    • irritability
    • desire to be held constantly
    • weak digestion
    • restless sleep
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY COLIC RELIEF 
    aethusa cynapium, aloe, carbo vegetabilis, chamomilla, colocynthis, mentha piperita, pulsatilla, senna, silicea, valeriana officinalis, zingiber officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0466
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM10 [hp_X]  in 59 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 59 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA10 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 59 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA10 [hp_X]  in 59 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA10 [hp_X]  in 59 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 59 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0466-21 in 1 CARTON03/02/2018
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/02/2018
    Labeler - King Bio Inc (617901350)
    Registrant - King Bio Inc (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(57955-0466)