Label: BABY GAS DROPS- silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice 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 December 1, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Argentum Nitricum 12X HPUS gas, stomach pressure and pain
    Asafoetida 6X HPUS swollen tummy, gas, restlessness
    Carbo Vegetabilis 12X HPUS gas especially after feeding, crying, burping
    Chamomilla 6X HPUS restlessness, fussiness, crying, groaning
    Cinchona Officinalis 6X HPUS gas discomfort, stomach pressure, colic, constipation
    Colocynthis 6X HPUS stomach pain and pressure, swollen tummy, disturbed sleep
    Lycopodium 30X HPUS hard tummy, bloating, burping
    Nux Moschata 6X HPUS stomach pressure, gas that disturbs sleep
    Sepia 12X HPUS hard, expanded tummy, stomach pressure and pain
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  • Uses

    Temporarily relieves the symptoms of gas, stomach pressure and pain, swollen tummy, restlessness, crying, burping, fussiness, groaning, gas discomfort, colic, constipation, disturbed sleep, hard tummy, and bloating.

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  • Warnings

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

    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.

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  • Directions

    • Measure only with the dosing dropper provided
    • Do not use dropper with other products
    • On dosing dropper, mL = milliliter
    • Fill to prescribed level and dispense liquid slowly into baby's mouth, toward inner cheek
    • For best results, clean dropper after each use

    Newborns and infants under 2 years of age (or weight under 24 lb)

    0.3 mL every 15 minutes for up to 8 doses until relieved; then every 2 hours as required.

    Children over 2 years of age (or weight over 24 lb)

    0.6 mL every 15 minutes for up to 8 doses until relieved; then every 2 hours as required.

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  • Other information

    • Do not use if imprinted foil inner seal is broken or missing
    • Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
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  • Inactive ingredients

    Citric Acid, Grape Flavor (natural), Hydroxyethyl Cellulose, Potassium Sorbate, Purified Water, Sodium Citrate, Vegetable Glycerine.

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  • Questions or comments?

    (800) 624-9659

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  • PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

    NDC 54973-3174-1

    HOMEOPATHIC

    SINCE 1903

    Hyland's®

    Baby

    Natural

    Relief

    Gas Drops

    NATURAL RELIEF OF GAS

    DISCOMFORT AND PAIN*

    ▶ No Alcohol, Artificial Flavors, Dyes or Sweeteners

    Natural Grape Flavor

    1 FL. OZ.

    (29.6 mL)

    carton

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  • INGREDIENTS AND APPEARANCE
    BABY GAS DROPS 
    silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3174
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 12 [hp_X]  in 1 mL
    FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT 6 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 6 [hp_X]  in 1 mL
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT 6 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X]  in 1 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 6 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    GRAPE (UNII: 6X543N684K)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3174-1 1 in 1 CARTON 01/15/2014
    1 29.6 mL 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 01/15/2014
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3174) , pack(54973-3174)
    Establishment
    Name Address ID/FEI Business Operations
    NEXGEN PHARMA, INC. 079424083 manufacture(54973-3174) , pack(54973-3174)
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