Label: BABY NIGHTTIME TINY COLD- matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet

  • Category: HUMAN OTC DRUG LABEL

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 27, 2021

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  • PURPOSE

    Relieves nasal congestion, runny nose, sneezing, cough and occasional sleeplessness

  • Drug Facts

    Active ingredients

    Purpose

    Chamomilla 6X HPUS

    occasional sleeplessness

    Eupatorium Perfoliatum 6X HPUS

    headache, cough, sneezing

    Euphrasia Officinalis 6X HPUS

    runny eyes/nose, nighttime coughing

    Gelsemium Sempervirens 6X HPUS

    sneezing, nasal congestion,occasional sleeplessness
    Kali Iodatum 6X HPUSheadache, runny eyes/nose

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

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves symptoms of common cold in children at night, including:

    ■ runny nose or eyes ■ cough ■ nasal congestion

    ■ headache ■ sneezing ■ occasional sleeplessness

  • 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 as needed. If symptoms persist,
    2 tablets every 4 hours during the night until relieved.
    Children 1 year
    to under 3 years     		At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
    3 tablets every 4 hours during the night 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

    NATURALS™

    •baby•

    Tiny Cold

    Tablets*

    Nighttime

    NO ARTIFICIAL FLAVORS,

    DYES or PARABENS

    Sleeplessness

    Nasal Congestions

    Runny Nose

    Sneezing

    Cough

    6+ MONTHS

    125

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME TINY COLD 
    matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem 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 CARTON12/28/2015
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3252-26 in 1 PACKET; Type 0: Not a Combination Product12/28/201512/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/28/2015
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3252) , pack(54973-3252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merical, Inc.029644978pack(54973-3252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3252) , pack(54973-3252) , label(54973-3252)
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