Label: BABY NIGHTTIME TINY COLD- chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid

  • NDC Code(s): 54973-3180-1, 54973-3180-2, 54973-3180-3
  • 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 1, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Chamomilla 6X HPUSoccasional sleeplessness
    Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
    Euphrasia Officinalis 6X HPUSrunny eyes and nose
    Gelsemium Sempervirens 6X HPUSsneezing with stuffy nose
    Kali Iodatum 6X HPUSheadache, runny eyes and nose
  • Uses

    Temporarily relieves the symptoms of common head colds in children, including: runny nose or eyes, cough, congestion, headache, sneezing,occasional sleeplessness

  • Warnings

    Consult a physician if: • symptoms persist for more 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 reach of children.

    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 medical professional.

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

    In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 houra 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 agevconsult a physician before using this product
    children 6 months to under 1 year of age2.5 mL up to 4 times daily (every 6 hours)
    children 1 to 3 years of age5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    • The inner packaged bottle is child-resistant.
    • Store at room temperature.
    • Do not refrigerate.
  • 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.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3180-1
    HOMEOPATHIC

    Ages

    6 months+

    Natural
    Relief

    SINCE 1903
    Hyland's

    Baby

    Nighttime


    Tiny Cold
    Syrup *

    RELIEF OF RUNNY NOSE,
    CONGESTION AND
    OCCASIONAL
    SLEEPLESSNESS
    DUE TO COLDS*

    ▶ No Alcohol, Artificial Flavors,
    Dyes or Parabens

    4 FL. OZ. (118 mL)

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME TINY COLD 
    chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3180-11 in 1 CARTON07/01/2014
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3180-25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2014
    3NDC:54973-3180-319.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2014
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3180) , pack(54973-3180)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXGEN PHARMA, INC.079424083manufacture(54973-3180) , pack(54973-3180)