Label: 4 KIDS STUFFY NOSE AND SINUS- pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate 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 March 4, 2020

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

  • Drug Facts

    Active ingredients

    Calcarea Carbonica 3X HPUS

    Hydrastis Canadensis 6X HPUS

    Kali Bichromicum 6X HPUS

    Pulsatilla Nigricans 6X HPUS

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

    Pharmacopœia of the United States.

    Purpose

    sinus pressure, congestion, headache

    sinus headache

    nasal congestion, sinus pressure

    sinus pressure, headache

  • Uses

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

    Children 2 years

    to under 6 years

    Dissolve 1 tablet under tongue every 4 hours

    until relieved, up to 72 hours.

    Children 6 years

    to under 12 years

    Dissolve 2 tablets under tongue every 4 hours

    until relieved, up to 72 hours.

    Adults and children

    12 years and over

    Dissolve 3 tablets under tongue every 4 hours

    until relieved, up to 72 hours.

  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    • The inner packaged bottle is child-resistant.
  • 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.

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    NDC 54973-3406-1

    2-12

    YEARS

    NEW

    4 KIDS

    SINCE 1903

    Hyland's

    Stuffy Nose

    & Sinus*

    Relieves nasal congestion,

    sinus preasure and headache

    NO ARTIFICIAL FLAVORS

    NO DYES or PARABENS

    NATURAL

    RELIEF

    50 QUICK-DISSOLVING

    TABLETS

    *SEE NOTE ON BACK

    PANEL BELOW DRUG FACTS

    SSFK 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
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]
    PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE6 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2020
    Labeler - Hyland’s Inc. (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3406) , pack(54973-3406) , label(54973-3406)