Label: BABY MUCUS AND 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
  • 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 July 31, 2018

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

  • Drug Facts

    Drug Facts

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Bryonia Alba 6X HPUSstubborn mucus in throat, cough with yellowish 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 expectoration of yellow mucus, chest congestion
    Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
    Rumex Crispus 6X HPUSrunny nose, sneezing
    Silicea 12X HPUSnasal congestion
  • Uses

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and 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 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 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 up to 4 times daily (every 6 hours)

    Children 1 to 3 years of age

    5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

  • Inactive ingredients

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

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3284-1

    HOMEOPATHIC

    Ages

    6 months+

    Natural

    Relief

    SINCE 1903

    Hyland's ®

    Baby

    Daytime

    Mucus +

    Cold Relief *

    LOOSENS MUCUS,

    RELIEF OF

    CONGESTION,

    RUNNY NOSE

    AND COUGH

    No Alcohol, No Artificial Flavors,

    Dyes or Parabens

    4 FL. OZ. (118 mL)

    carton

  • INGREDIENTS AND APPEARANCE
    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
    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
    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
    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 Product12/23/2016
    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 (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3284) , pack(54973-3284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(54973-3284) , pack(54973-3284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220pack(54973-3284)