BABY NIGHTTIME TINY COLD (MATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET [HYLAND'S]

BABY NIGHTTIME TINY COLD (MATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET [HYLAND'S]
PDF | XML

NDC 54973-3252-1, 54973-3252-2
Set ID 275f18d5-739e-4055-9553-10ae2be836ad
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Chamomilla 6X HPUSoccasional sleeplessness
    Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
    Euphrasia Officinalis 6X HPUSrunny eyes, nose and nighttime coughing
    Gelsemium Sempervirens 6X HPUSsneezing with stuffy nose and occasional sleeplessness
    Kali Iodatum 6X HPUSheadache, runny eyes & nose and occasional sleeplessness
  • Uses

    Temporarily relieves the symptoms of runny nose and eyes, nighttime cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

  • Warnings

    Consult a physician if:

    • symptoms persist for more than 72 hours or worsen
    • symptoms are accompanied by a high fever (over 101°F)

    Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

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

    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 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 tongue every 4 hours during the night as required.

    Children 1 to 3 years of age

    Dissolve 3 tablets on tongue every 4 hours during the night as required.

    Hyland's Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

    Ages

    6 months+

    NDC 54973-3252-1

    HOMEOPATHIC

    SINCE 1903

    Hyland's®

    Baby

    Natural

    Relief

    Nighttime

    Tiny Cold

    Tablets

    RELIEF OF RUNNY NOSE,

    CONGESTION, AND

    OCCASIONAL SLEEPLESSNESS

    DUE TO COLDS*

    ▶ No Artificial Flavors, Dyes or Parabens

    125 QUICK-DISSOLVING TABLETS

    1

  • 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 Product12/28/2015
    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)

Related Drugs