Label: TINY COLD- eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, soluble

  • NDC Code(s): 54973-3158-1, 54973-3158-2, 54973-3158-4
  • 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 October 10, 2023

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

  • PURPOSE

    Relieves nasal congestion, runny nose, sneezing and cough

  • Drug Facts

    Active ingredients

    Purpose

    Eupatorium Perfoliatum 6X HPUS

    headache, cough, sneezing

    Euphrasia Officinalis 6X HPUS

    runny eyes/nose

    Gelsemium Sempervirens 6X HPUS

    sneezing, nasal congestion

    Kali Iodatum 6X HPUS

    headache, runny eyes/nose

    "HPUS" indicates that the active ingredients are in the official Homeopathic

    Pharmacopoeia of the United States.

  • Uses

    ■ Helps temporarily relieves 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 monthsAsk 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

  • 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 - 125 Tablet Bottle Carton

    Hyland's

    NATURAL™

    •baby•

    Tiny Cold

    Tablets

    DAYTIME

    NO ARTIFICIAL FLAVORS

    DYES or PARABENS

    Nasal Congestion

    Runny Nose

    Sneezing

    Cough

    6+ MONTHS

    125

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    TINY COLD 
    eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [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]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (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 CARTON12/28/2011
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3158-46 in 1 PACKET; Type 0: Not a Combination Product12/28/201112/29/2021
    3NDC:54973-3158-21 in 1 CARTON12/28/201112/29/2021
    3135 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/28/2011
    Labeler - Hyland's Inc. (008316655)