Label: BABY MUCUS PLUS COLD RELIEF DAY AND NIGHT VALUE PACK- 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 October 30, 2018

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

  • DAYTIME

    Drug Facts

    Active ingredients

    Bryonia Alba 6X HPUS

    Euphrasia Officinalis 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Natrum Muriaticum 30X HPUS

    Phosphorus 30X HPUS

    Pulsatilla 6X HPUS

    Rumex Crispus 6X HPUS

    Silicea 12X HPUS

    “HPUS” indicates that the active ingredients are in the

    official Homeopathic Pharmacopœia of the United States.

    Purpose

    Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus

    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

    Natrum Muriaticum 30X HPUS....accumulation of mucus in throat, cough up mucus

    Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion

    Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

    Rumex Crispus 6X HPUS.................runny nose, sneezing

    Silicea 12X HPUS...................................nasal congestion

    Uses

    Temporarily relieves the symptoms of colds, including: • accumulation of mucus in chest, throat and nose • cough with mucus 

    • runny nose • sneezing • nasal congestion

    Warnings

    Consult a physician if

    symptoms persist for more than 7 days or worsen. inflammation, fever or infection develops. symptoms are accompanied by a high fever (over 101°F). cough tends to recur or is accompanied by a high fever, rash or persistent headache.

    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.

    Do not use this product for

    persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

    A persistent cough may be a sign of a serious condition

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing.

    The inner packaged bottle is child-resistant

    In case of emergency

    contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

    Directions

    Measure only with the dosing syringe provided

    Do not use dosing syringe with other products

    On dosing syringe, mL = milliliter, tsp = teaspoon

    Drug Facts (continued)

    Children under

    6 months of age

    consult a licensed health care

    professional before using this

    product

    Children 6 months to

    under 1 year of age

    2.5 mL or ½ tsp up to

    4 times daily (every 6 hours)

    Children 1 to 3

    years of age

    5 mL or 1 tsp up to

    6 times daily (every 4 hours)

    Inactive ingredients

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

  • NIGHTTIME

    Active ingredients

    Allium Cepa 6X HPUS

    Bryonia Alba 6X HPUS

    Chamomilla 3X HPUS

    Coffea Cruda 3X HPUS

    Euphrasia Officinalis 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 30X HPUS

    Pulsatilla 6X HPUS

    Rumex Crispus 6X HPUS

    Silicea 12X HPUS

    Sulphur 12X HPUS

    “HPUS” indicates that the active ingredients are in the

    official Homeopathic Pharmacopœia of the United States.

    Purpose

    Allium Cepa 6X HPUS......runny nose with mucus, hacking cough, sore throat

    Bryonia Alba 6X HPUS.............. stubborn mucus in throat, cough with yellowish mucus

    Chamomilla 3X HPUS.......irritability, fussiness, occasional sleeplessness

    Coffea Cruda 3X HPUS...............occasional sleeplessness, restlessness

    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 expectoration of yellow mucus, chest congestion

    Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

    Rumex Crispus 6X HPUS............runny nose and sneezing

    Silicea 12X HPUS.....................................nasal congestion

    Sulphur 12X HPUS...............cough with thick mucus, chest congestion, nasal congestion

    Uses

    Temporarily relieves the symptoms of colds,including: accumulation of mucus in chest, throat and nose cough with mucus 

    runny nose sneezing •nasal congestion irritability fussiness occasional sleeplessness

    Drug Facts (continued)

    Warnings

    Consult a physician if:

    symptoms persist for more than 7 days or worsen. inflammation, fever or infection develops. symptoms are accompanied by high fever (101°F). cough tends to recur or is accompanied by high fever, rash or persistent headache.

    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.

    Do not use this product for

    persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unles directed by a licensed health care professional.

    A persistent cough may be a sign of a serious condition.

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing.

    The inner packaged bottle is child-resistant.

    The inner packaged bottle is child-resistant.

    In case of emergency

    contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

    Directions

    • Measure only with the dosing syringe provided
    • Do not use dosing syringe with other products
    • On dosing syringe, mL = milliliter, tsp = teaspoon

    Children under

    6 months of age

    consult a licensed health care professional

    before using this product

    Children 6 months to

    under 1 year of age

    2.5 mL or ½ tsp at bedtime and every

    6 hours during the night or as necessary

    Children 1 to 3

    years of age

    5 mL or 1 tsp at bedtime and every 4 hours

    during the night or as necessary

    Inactive ingredients

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

    Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • PRIMARY DISPLAY PANEL - Day & Night Value Pack Kit

    NDC 54973-3374-1

    HOMEOPATHIC

    Ages

    6 months+

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    baby

    Mucus + Cold Relief*

    Day & Night Value Pack

    Daytime

    LOOSENS MUCUS,

    RELIEF OF

    CONGESTION,

    RUNNY NOSE

    AND COUGH

    ALCOHOL FREE

    4 FL. OZ. (118 mL) Daytime

    Nighttime

    LOOSENS MUCUS,

    RELIEF OF

    CONGESTION

    AND OCCASIONAL

    SLEEPLESSNESS

    DUE TO COLDS

    LESS THAN 0.2% ALCOHOL

    4 FL. OZ. (118 mL) Nighttime

    No Artificial Flavors, Dyes or Parabens

    8 FL. OZ. (236 mL) TOTAL

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY MUCUS PLUS COLD RELIEF DAY AND NIGHT VALUE PACK 
    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, PLASTIC 118 mL
    Part 1 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, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Part 2 of 2
    BABY MUCUS AND 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
    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
    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
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)