Label: BABY NIGHTTIME MUCUS PLUS COLD RELIEF- calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla liquid

  • NDC Code(s): 54973-3371-1, 54973-3371-2, 54973-3371-3
  • 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 April 17, 2023

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  • Purpose

    Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

  • Drug Facts

    Active ingredients

    Purpose

    Allium Cepa 6X HPUS

    runny nose with mucus, hacking cough, sore throat

    Bryonia Alba 6X HPUS

    stubborn mucus in throat, cough with mucus

    Chamomilla 3X HPUS

    occasional sleeplessness

    Coffea Cruda 3X HPUS

    occasional sleeplessness

    Euphrasia Officinalis 6X HPUS

    cough with mucus in chest

    Hepar Sulph Calc 12X HPUS

    cough up mucus, mucus rattle with cough, stubborn mucus in chest

    Hydrastis 6X HPUS

    cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat

    Natrum Muriaticum 6X HPUS

    accumulation of mucus in throat, cough up mucus

    Phosphorus 30X HPUS

    cough with mucus, chest congestion

    Pulsatilla 6X HPUS

    accumulation of mucus, discharge of mucus, loose cough

    Rumex Crispus 6X HPUS

    runny nose, sneezing

    Silicea 12X HPUS

    nasal congestion

    Sulfur 12X HPUS

    cough with thick mucus, chest congestion, nasal congestion

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves symptoms of common cold in children at night, including: ■ accumulation of mucus in chest, throat or nose

    ■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion ■ occasional sleeplessness

  • Warnings

    Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 year     		2.5 mL at bedtime and every 6 hours
    during the night until relieved.
    Children 1 year
    to under 3 years     		5 mL at bedtime and every 4 hours
    during the night until relieved.

  • Inactive ingredients

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

  • Questions?

    www.hylands.com or care@hylands.com

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

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

  • HOMEOPATHIC ACTIVE INGREDIENTS 10%

  • PRINCIPAL DISPLAY PANEL

    Carton

  • PRINCIPAL DISPLAY PANEL

    carton2

  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME MUCUS PLUS COLD RELIEF 
    calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3371
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    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
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3371-11 in 1 CARTON11/01/201812/27/2021
    1148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3371-21 in 1 CARTON11/01/2018
    2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:54973-3371-32.5 mL in 1 PACKET; Type 0: Not a Combination Product11/01/201812/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3371) , pack(54973-3371) , label(54973-3371)
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