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

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 healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

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

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  • 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

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  • 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 agev consult a physician before using this product
    children 6 months to under 1 year of age 2.5 mL 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)

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  • 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.
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  • Inactive ingredients

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

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  • Questions or comments?

    (800) 624-9659

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  • SPL UNCLASSIFIED SECTION

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME TINY COLD 
    chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3180
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3180-1 1 in 1 CARTON 07/01/2014
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3180-2 5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2014
    3 NDC:54973-3180-3 19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/01/2014
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3180) , pack(54973-3180)
    Establishment
    Name Address ID/FEI Business Operations
    NEXGEN PHARMA, INC. 079424083 manufacture(54973-3180) , pack(54973-3180)
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