Label: BABY TINY COLD DAYTIME AND NIGHTTIME- eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kit

  • NDC Code(s): 54973-3158-1, 54973-3252-1, 54973-3307-1
  • Packager: Hyland's Inc.
  • 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 November 28, 2022

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  • DAYTIME

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
    Euphrasia Officinalis 6X HPUSrunny eyes/nose
    Gelsemium Sempervirens 6X HPUSsneezing, nasal congestion
    Kali Iodatum 6X HPUSheadache, runny eyes/nose

    "HPUS” is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion ■ headache ■ sneezing ■ cough

  • 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.

    Children under 6 months:Ask a doctor before use.
    Children 6 months to under 1 year:At onset of symptoms, dissolve 2 tablets on tongue every hour
    up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
    Children 1 year to under 3 years:At onset of symptoms, dissolve 3 tablets on tongue every hour
    up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • NIGHTTIME

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Chamomilla 6X HPUSoccasional sleeplessness
    Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
    Euphrasia Officinalis 6X HPUSrunny eyes/nose, nighttime coughing
    Gelsemium Sempervirens 6X HPUSsneezing, nasal congestion
    Kali Iodatum 6X HPUSheadache, runny eyes/nose

    "HPUS” is the Homeopathic Pharmacopoeia of the United States.

  • Uses

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

  • NIGHTTIME Drug Facts (continued)

  • 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

    Children under 6 months:Ask a doctor before use.
    Children 6 months to under 1 year:At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved.
    Children 1 year to under 3 years:At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

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

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

  • PURPOSE

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

  • Principal Display Panel

    Hyland's

    NATURALS

    •baby•

    Tiny Cold Tablets*

    COMBO PACK

    NO ARTIFICIAL FLAVORS, PARABENS or DYES

    DAYTIME

    Nasal Congestion

    Runny Nose

    Sneezing

    Cough

    NIGHTTIME

    Sleeplessness

    Nasal Congestion

    Runny Nose

    Sneezing

    Cough

    6+ MONTHS

    2 x 125 CT BOTTLES

    (1 DAY, 1 NIGHT)

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY TINY COLD DAYTIME AND NIGHTTIME 
    eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3307
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3307-11 in 1 CARTON01/11/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 125 
    Part 21 BOTTLE, PLASTIC 125 
    Part 1 of 2
    TINY COLD 
    eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, soluble
    Product Information
    Item Code (Source)NDC:54973-3158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3158-11 in 1 CARTON
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/28/2015
    Part 2 of 2
    BABY NIGHTTIME TINY COLD 
    matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
    Product Information
    Item Code (Source)NDC:54973-3252
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3252-11 in 1 CARTON
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/11/2017
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc008316655manufacture(54973-3307) , pack(54973-3307) , label(54973-3307)
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