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 Inc.
  • 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 November 29, 2022

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  • Drug Facts

    Drug Facts

    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 symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion
    ■ headache ■ sneezing ■ occasional sleeplessness

  • Warnings

    Ask a doctor before use if you have:

    ■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious
    condition. ■ cough that is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if:

    ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.  Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.

    Children under 6 monthsAsk a doctor before use.
    Children 6 months
    to under 1 year     		2.5 mL at bedtime and every 6 hours
    during the night until relieved.
    Children 1 year
    to under 3 years     		5 mL at bedtime and every 4 hours
    during the night until relieved.

  • Inactive ingredients

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

  • Questions?

    (800) 624-9659

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

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Hyland's

    NATURALS

    •baby•

    Tiny Cold

    Syrup

    NIGHTTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    Sleeplessness

    Congestion

    Runny Nose

    Sneezing

    6+ MONTHS

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    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
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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 Product07/01/201412/27/2021
    3NDC:54973-3180-319.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201412/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2014
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3180) , pack(54973-3180)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(54973-3180) , pack(54973-3180) , label(54973-3180)
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