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 18, 2017

If you are a consumer or patient 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 runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

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  • Warnings

    Do not use

    • for persistent or chronic cough such as occurs with asthma, smoking or emphysema
    • 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.

    Stop use and ask a doctor if

    • symptoms persist for more than 7 days or worsen
    • 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 reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately.

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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 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)
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  • Other information

    • do not use if imprinted tamper band is broken or missing
    • Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
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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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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3180-1

    HOMEOPATHIC

    Ages

    6 months+

    SINCE 1903
    Hyland's

    Baby

    Natural
    Relief

    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)

    1

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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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