Label: CHILDRENS COLD AND COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid

  • 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 4, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

    Active ingredients

    Allium Cepa 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 12X HPUS

    Pulsatilla 6X HPUS

    Sulphur 12X HPUS

    “HPUS” indicates that the active ingredients are in the

    official Homeopathic Pharmacopœia of the United States.

    Allium Cepa 6X HPUS................watery/runny nose, cold,hacking cough, painful throat

    Hepar Sulph Calc 12X HPUS.......................cold, sneezing

    Hydrastis 6X HPUS...............rattling/tickling cough, sinus congestion, dry/raw/sore throat

    Natrum Muriaticum 6X HPUS........dry cough, sore throat

    Phosphorus 12X HPUS...............hoarse/dry cough, nasal congestion, chest congestion

    Pulsatilla 6X HPUS...............................moist cough, cold, nasal congestion

    Sulphur 12X HPUS.....................chest congestion, nasal congestion, sneezing, runny nose

  • Uses

    Temporarily relieves the symptoms of the common cold, including: nasal or chest congestion,runny nose,sore throat,sneezing cough

  • Warnings

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

    Consult a physician if

    • symptoms persist for more than 7 days or worsen.
    • inflammation, fever or infection develops.
    • symptoms are accompanied by a high fever (over 101°F).
    • cough tends to recur or is accompanied by a high fever, rash or persistent headache.

    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 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 health care 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 high fever, headache, nausea,

    and vomiting may be serious. Consult a doctor promptly.

    Do not use if imprinted tamper-evident bottle cap band
    is broken or missing.

    The inner packaged bottle is child-resistant

    In case of emergency, contact a medical professional or Poison Control Center immediately.

  • Drug Facts (continued)

    Directions

    • Measure only with the dosing cup provided
    • Do not use dosing cup with other products
    • On dosing cup, mL = milliliter

    Children 2 years

    to under 6 years

    5 mL up to 6 times

    per day (every 4 hours)

    Children 6 years

    to under 12 years

    10 mL up to 6 times

    per day (every 4 hours)

    Adults and children

    12 years and over

    15 mL up to 6 times

    per day (every 4 hours)

  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Questions or comments?

    1-800-925-4733

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens

    100% SATISFACTION

    GUARANTEED

    walgreens.com ©2018 Walgreen Co.

  • PRINCIPAL DISPLAY PANEL-4 FL OZ (118 mL) Bottle Carton

    Walgreens

    Compare to Hyland’s 4 Kids

    Cold ’n Cough Natural Grape Flavor

    NDC 0363-9999-01

    NEW

    children's

    HOMEOPATHIC*

    Dye-Free

    Cold &

    Cough

    DYE FREE

    ALCOHOL FREE

    SUGAR FREE

    AGES

    2-12

    YEARS

    GRAPE

    FLAVOR

    4 FL OZ (118 mL)

    carton

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND COUGH GRAPE FLAVOR 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9999
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9999-011 in 1 CARTON12/14/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/14/2018
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(0363-9999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc079424083manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)