Label: BABY TINY COLD- euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens, kali iodatum tablet, orally disintegrating

  • 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 January 6, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients HPUS*

    Euphrasia officinalis 6X

    Eupatorium perfoliatum 6X

    Gelsemium sempervirens 6X

    Kali iodatum 6X

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Euphrasia officinalis 6X..................................Runny eyes and nose

    Eupatorium perfoliatum 6X.............................Sneezing, cough, headache

    Gelsemium sempervirens 6X...........................Stuffy nose, sneezing

    Kali iodatum 6X.............................................Runny eyes and nose, headache

  • USES

    Temporarily relieves the symptoms of runny nose, congestion and sneezing due to common head colds in children.*

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • WARNINGS

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

    Consult a physician if symptoms persist for more than 72 hours or worsen; if symptoms are accompanied by a high fever (over 101°F).

    Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.

    Do not use if security seal is broken or missing.

  • 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 the tongue every 15 minutes for 4 doses, then hourly until relieved, or as directed by a licensed health care professional.

    Children 1 to 3 years of age: Dissolve 3 tablets on the tongue every 15 minutes for 4 doses, then hourly until relieved, or as directed by a licensed health care professional.

    CVS Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

  • STORAGE AND HANDLING

    Store at room temperature (68-77°F)

  • Inactive Ingredients

    Lactose

  • PRINCIPAL DISPLAY PANEL

    image of box text

  • INGREDIENTS AND APPEARANCE
    BABY TINY COLD 
    euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens, kali iodatum tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-371
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 125 
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 125 
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 125 
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION6 [hp_X]  in 125 
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-371-03125 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/06/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-371)