Label: 4 KIDS STUFFY NOSE AND SINUS- pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tablet

  • NDC Code(s): 54973-3406-1, 54973-3406-2
  • Packager: Hyland’s Inc.
  • 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 March 6, 2023

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  • PURPOSE

    Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Calcarea Carbonica 3X HPUSsinus pressure, congestion, headache
    Hydrastis Canadensis 6X HPUSsinus headache
    Kali Bichromicum 6X HPUSnasal congestion, sinus pressure
    Pulsatilla Nigricans 6X HPUSsinus pressure, headache

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:

    ■ nasal congestion

    ■ sinus pressure

    ■ headache

  • Warnings

    Stop use and ask a doctor if

    ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever.

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.

    Children 2 years
    to under 6 years     		At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist,
    1 tablet every 4 hours until relieved.
    Children 6 years
    to under 12 years     		At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist,
    2 tablets every 4 hours until relieved.
    Adults and children
    12 years and over     		At onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours. If symptoms persist,
    3 tablets every 4 hours until relieved.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

  • *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

    Hyland's

    NATURALS™

    •kids•

    STUFFY NOSE

    & SINUS*

    NO ARTIFICIAL FLAVORS,
    DYES or PARABENS

    Nasal Congestion
    Sinus Pressure
    Headache

    2- 12 YEARS

    50

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS STUFFY NOSE AND SINUS 
    pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]
    PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3406-11 in 1 CARTON01/27/2020
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3406-21 in 1 CARTON01/27/202003/06/2023
    216 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2020
    Labeler - Hyland’s Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3406) , pack(54973-3406) , label(54973-3406)
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