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

  • ACTIVE INGREDIENT

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

  • 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.

  • 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.

  • 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
  • Inactive ingredients

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

  • Questions or comments?

    (800) 624-9659

  • 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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3174
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE12 [hp_X]  in 1 mL
    FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT6 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK6 [hp_X]  in 1 mL
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT6 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]  in 1 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG6 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3174-11 in 1 CARTON01/15/2014
    129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/15/2014
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3174) , pack(54973-3174)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXGEN PHARMA, INC.079424083manufacture(54973-3174) , pack(54973-3174)