Label: 4KIDS COMPLETE COLD N FLU- cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet

  • 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 3, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Anas Barbariae Hepatis Et Cordis Extractum 200C HPUSearly onset flu symptoms
    Bryonia 6X HPUSbody aches, headaches, cough
    Eupatorium Perfoliatum 6X HPUSbody aches, headaches, cough
    Euphrasia Officinalis 6X HPUSrunny nose, cough, fever, chills, congestion
    Gelsemium Sempervirens 6X HPUSaches and pain, fever, fatigue
    Kali Iodatum 3X HPUSheadache, runny nose, fever, sore throat
  • Uses

    Temporarily relieves the symptoms of the common cold and flu including body aches and headaches, cough and congestion, fever, chills, and sore throat.

  • Warnings

    As with any drug, ask a doctor before use if pregnant or nursing.

    Consult a physician if:

    • Symptoms persist for more than 7 days or worsen
    • Inflammation, fever or infection develops
    • 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 the reach of children.

    In case of accidental overdose, contact a medical professional or a Poison Control Center immediately.

    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 health care professional.

    A persistent cough may be a sign of a serious condition.

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

    Do not use if imprinted tamper band is broken or missing.

    There have been no reports of interactions between this product and ibuprofen or acetaminophen.

    In case of emergency, 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 2 years to under 6 yearsdissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Children 6 years to under 12 yearsdissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Adults and children 12 years and overdissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
  • Inactive ingredients

    Acacia Gum, Lactose N.F.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

    NDC 54973-3241-1
    HOMEOPATHIC*

    Natural
    Relief

    Ages
    2-12

    SINCE 1903
    Hyland's

    4Kids
    Complete
    Cold 'n Flu

    Body Aches & Headache

    Cough & Congestion

    Fever & Chills

    Sore Throat

    125
    QUICK-DISSOLVING
    TABLETS

    SAFE &
    EFFECTIVE

    PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    4KIDS COMPLETE COLD N FLU 
    cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3241
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE200 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [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 IODIDE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3241-11 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 HOMEOPATHIC10/30/2015
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655MANUFACTURE(54973-3241) , PACK(54973-3241)