Label: COLD- aconitum napellus, allium cepa, gelsemium semp., zincum gluconicum 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 December 7, 2022

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  • PURPOSE

    Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever

  • Drug Facts

    Active ingredientsPurpose
    Aconitum Napellus 6X HPUSsneezing, watery eyes, sore throat
    Allium Cepa 6X HPUSred/watery eyes, runny nose, nasal discharge
    Gelsemium Sempervirens 6X HPUSsneezing, headache, sore throat, cough
    Zincum Gluconicum 2X HPUSrunny nose, sore throat

    "HPUS" indicates that the active ingredients are in the official Homeopathic
    Pharmacopœia of the United States.

  • Uses

    ■ Reduces the duration and severity of common cold symptoms
    ■ Temporarily relieves symptoms of common cold, including:
    ■ sneezing ■ runny nose ■ congestion
    ■ cough ■ sore throat ■ headache
    ■ watery eyes ■ fever ■ chills

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use more than directed.

    Consult a physician if:

    ■ symptoms persist for more than 7 days or worsen.
    ■ inflammation, fever (over 101°F) or infection is present or develops.
    ■ cough tends to recur or is accompanied by a fever (over 101°F), 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.

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by fever (over 101°F), headache, nausea and vomiting may be serious. Consult a doctor promptly.

    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

    Adults and children
    12 years and over     		Dissolve 2 tablets under tongue every 4 hours until relieved.
    Children 6 years
    to under 12 years     		Dissolve 1 tablet under tongue every 4 hours until relieved.

  • Drug Facts (continued)

    Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

  • 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.

  • PACKAGE LABEL- PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC
    NDC 54973-3010-1

    AGES 6+

    SINCE 1903

    Hyland's

    Cold Tablets

    with Zinc*

    SHORTENS

    COLDS

    MULTI - SYMPTOM RELIEF

    Relieves Runny Nose, Congestion, Sore Throat,
    Cough, Sneezing, Headache and Fever

    Free of Dyes and Preservatives
    Non-Drowsy

    50 QUICK-DISSOLVING

    TABLETS

    NATURAL

    RELIEF

    *SEE NOTE ON SIDE PANEL BELOW DRUGS FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    COLD 
    aconitum napellus, allium cepa, gelsemium semp., zincum gluconicum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 g
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 g
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 g
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3010-11 in 1 CARTON02/17/1997
    11 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/1997
    Labeler - Hyland's Inc. (008316655)
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