Label: BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME- 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 kit

  • NDC Code(s): 54973-3284-1, 54973-3371-2, 54973-3374-1
  • Packager: Hyland's
  • 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 November 10, 2021

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

  • PURPOSE

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

  • DAYTIME

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

    Uses

    ■ Temporarily relieves 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 months
    Ask a doctor before use.
    Children 6 months
    to under 1 year
    2.5 mL up to 4 times per day
    (every 6 hours).
    Children 1 year
    to under 3 years
    5 mL up to 6 times per day
    (every 4 hours).

    Inactive ingredients

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

  • NIGHTTIME

    Drug Facts

    Active ingredientsPurpose
    Allium Cepa 6X HPUSrunny nose with mucus, hacking cough, sore throat
    Bryonia Alba 6X HPUSstubborn mucus in throat, cough with mucus
    Chamomilla 3X HPUSoccasional sleeplessness
    Coffea Cruda 3X HPUSoccasional sleeplessness
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Hydrastis 6X HPUScough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat
    Natrum Muriaticum 6X 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
    Sulfur 12X HPUScough 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

    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 months
    Ask 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 relieve

  • Drug Facts (continued)

    Inactive ingredients

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

    Questions?

    (800) 624-9659

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

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

  • Primary Display Panel - Day & Night Combo Pack Kit

    Hyland's

    NATURALS™

    •baby•

    Mucus + Cold Relief

    COMBO PACK

    NO SUGAR

    PARABENS or DYES*

    DAYTIME

    Mucus

    Congestion

    Runny Nose

    Sneezing

    Cough

    NIGHTTIME

    Sleeplessness

    Mucus

    Congestion

    Runny Nose

    Sneezing

    Cough

    6+ MONTHS

    DAYTIME - NO ALCOHOL

    NIGHTTIME - LESS THAN 0.2% ALCOHOL

    TWO - 4 FL. OZ. (118 mL) ( 1 Day, 1 Night) | TOTAL 8 FL. OZ. (236 mL)

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME 
    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 kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3374
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3374-11 in 1 CARTON; Type 0: Not a Combination Product11/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    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
    Item Code (Source)NDC:54973-3284
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [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
    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
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3284-1118 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
    Part 2 of 2
    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
    Item 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
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [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
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3371-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Labeler - Hyland's (028570695)
    Registrant - Standard Homeopathic Company (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)