Label: BABY TINY COLD DAY AND NIGHT VALUE PACK- 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
  • 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 May 4, 2020

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

  • DAYTIME

    Drug Facts

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

    Uses

    ■ Temporarily relieves symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion

    ■ headache ■ sneezing ■ cough

    Warnings

    Consult a physician if: ■ symptoms persist for more than 72 hours 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 the reach of children.

    Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed 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 hours a day, 7 days per week at (800) 624-9659.

    Directions

    Children under 6 months of age: consult a licensed health care professional before using this product.

    Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

    Children 1 to 3 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

    Hyland's Baby Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

    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.

  • Drug Facts (continued)

    Inactive ingredients

    Acacia Gum, Lactose.

  • NIGHTTIME

    Drug Facts

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

    Uses

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

    Warnings

    Consult a physician if: ■ symptoms persist for more than 72 hours 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 the reach of children.

    Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed 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 hours a day, 7 days per week at (800) 624-9659.

  • Drug Facts (continued)

    Directions

    Children under 6 months of age: consult a licensed health care professional before using this product.

    Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 4 hours during the night as required.

    Children 1 to 3 years of age: dissolve 3 tablets on tongue every 4 hours during the night as required.

    Hyland's Baby Nighttime Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

    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.

    Inactive ingredients

    Acacia Gum, Lactose.

    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 - Kit Carton

    VALUE PACK

    HOMEOPATHIC

    NDC 54973-3307-1

    6+

    MONTHS

    NEW

    LOOK

    BABY

    SINCE 1903

    Hyland's

    Tiny Cold Tablets*

    DAYTIME

    Relieves nasal

    congestion, runny nose,

    sneezing and cough

    NIGHTTIME

    Relieves nasal congestion,

    runny nose, sneezing, cough

    and occasional sleeplessness

    NO ARTIFICIAL FLAVORS, DYES or PARABENS

    NATURAL

    RELIEF

    TWO - 125 Quick-Dissolving Tablet Bottles (1 Day, 1 Night)

    TOTAL 250 Quick-Dissolving Tablets

    *SEE NOTE ON SIDE

    PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    BABY TINY COLD DAY AND NIGHT VALUE PACK 
    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 (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3307) , pack(54973-3307) , label(54973-3307)