Label: COUGH BABY- ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root syrup

  • NDC Code(s): 54973-3154-1, 54973-3154-2
  • Packager: Hyland's Inc.
  • 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 12, 2022

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  • PURPOSE

    Relieves coughs in babies

  • Drug Facts

    Active ingredients

    Purpose

    Bryonia Alba 6X HPUS

    dry cough

    Causticum 6X HPUS

    hoarse cough

    Drosera Rotundifolia 6X HPUS

    barking cough

    Ipecacuanha 6X

    gagging cough

    Phosphorus 12X HPUS

    tight cough

    Rumex Crispus 6X HPUS

    dry cough

    Spongia Tosta 6X HPUS

    tickling cough

    "HPUS" indicates that the active ingredients are in the official Homeopathic

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

  • Warnings

    Ask a doctor before use if you have:

    ■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if:

    ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

    Keep out of reach of children.

    Keep this and all medications out of the reach of children.

  • Directions

    ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.  Measure
    only with the dosing syringe provided. ■ Do not use dosing syringe with other
    products. ■ On dosing syringe, mL = milliliter.

    Children under 6 monthsAsk a doctor before use.
    Children 6 months to under 1 year2.5 mL up to 4 times per day (every 6 hours).
    Children 1 year to under 3 years5 mL up to 6 times per day (every 4 hours).

  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

  • Questions?

    (800) 624-9659

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

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

  • PACKAGE LABEL-118 mL BOTTLE CARTON

    Hyland's

    NATURALS™

    •baby•

    Cough

    Syrup*

    DAYTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    6+ MONTHS

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    COUGH BABY 
    ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM6 [hp_X]  in 1 mL
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3154-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2012
    2NDC:54973-3154-119.81 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/17/201212/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/17/2012
    Labeler - Hyland's Inc. (008316655)
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