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
  • 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 31, 2018

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

  • Drug Facts

    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

    Pharmacopoeia 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 symptoms of colds, including accumulation of

    mucus in chest, throat and nose, cough with mucus, runny nose, sneezing,

    nasal congestion and irritability, fussiness and occasional sleeplessness.

    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 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.

    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 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.

  • Drug Facts (continued)

    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 teaspoon at

    bedtime and every 6 hours

    during the night or as necessary.

    Children 1 to 3

    years of age

    5 mL or 1 teaspoon 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

  • Principal Display Panel - 148 mL Bottle Label Carton

    25% FREE

    BONUS PACK

    NDC 54973-3371-1

    HOMEOPATHIC

    Ages

    6 months+

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    baby

    Nighttime

    Mucus +

    Cold Relief*

    LOOSENS MUCUS,

    RELIEF OF

    CONGESTION,

    AND OCCASIONAL

    SLEEPLESSNESS

    DUE TO COLDS

    No Artificial Flavors,

    Dyes or Parabens

    LESS THAN 0.2% ALCOHOL

    4 + 1 = 5 FL. O Z. (148 mL)

    carton

  • 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 CARTON11/01/2018
    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 Product11/01/2018
    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(54973-3371) , pack(54973-3371) , label(54973-3371)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3371) , pack(54973-3371) , label(54973-3371)