Label: BABY MUCUS PLUS COLD RELIEF- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

  • NDC Code(s): 54973-3284-1, 54973-3284-2, 54973-3284-3
  • 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 August 22, 2023

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  • Drug Facts

    Active ingredientsPurpose*
    Bryonia Alba 6X HPUSstubborn mucus in throat, cough with mucus
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
    Phosphorus 30X HPUScough with mucus, chest congestion
    Pulsatilla 6X HPUSaccumulation of mucus, discharge of mucus, loose cough
    Rumex Crispus 6X HPUSrunny nose, sneezing
    Silicea 12X HPUSnasal congestion

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses*

    ■ Helps temporarily relieve symptoms of common cold in children, including:
    ■ accumulation of mucus in chest, throat or nose
    ■ cough with mucus ■ runny nose ■ sneezing
    ■ nasal or chest congestion

  • 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

  • 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?

    www.hylands.com or care@hylands.com

  • HOMEOPATHIC ACTIVE INGREDIENTS 10%

  • SPL UNCLASSIFIED SECTION

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

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

  • PURPOSE

    Helps temporarily relieve symptoms of common cold in children, including: accumulation of mucus in chest, throat or nose, cough with mucus, runny nose, sneezing, nasal or chest congestion.

  • Principal Display Panel

    Hyland's

    NATURALS™

    •baby•

    Mucus + Cold

    Relief

    D AYTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    Mucus*

    Congestion*

    Runny Nose*

    Sneezing*

    Cough*

    6+ MONTHS

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    BABY MUCUS PLUS COLD RELIEF 
    bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3284
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3284-11 in 1 CARTON05/13/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3284-22.5 mL in 1 POUCH; Type 0: Not a Combination Product12/23/201612/20/2021
    3NDC:54973-3284-31 in 1 CARTON08/01/2018
    3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/13/2016
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3284) , pack(54973-3284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220pack(54973-3284)
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