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

  • 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 April 29, 2019

If you are a consumer or patient 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 Pharmacoœia of the United States.

    Purpose

    Allium Cepa 6X HPUS.................watery/runny nose, cold, hacking cough, sore 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 or cough.

  • Drug Facts (continued)

    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 high fever (101°F)
    • Cough tends to recur or is accompanied by 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 medical 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.

    In case of emergency

    contact a medical professional or Poison Control Center immediately.

  • Directions

    • Shake well before using.
    • 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)

  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    • This package is child-resistant.
    • Store at room temperature.
    • Do not refrigerate.
  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

  • Questions or Comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

    NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Primary Display Panel - 118 mL Bottle Label

    Walgreens

    NDC 0363-9997-01

    children's

    DAYTIME

    Dye-Free

    Cold & Cough

    DYE FRE SUGAR FREE

    ALCOHOL FREE

    • Homeopathic

    AGES

    2-12

    YEARS

    FLAVOR FREE

    4 FL.OZ. (118 mL)

    LABEL

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND COUGH 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9997
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9997-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2019
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(0363-9997) , pack(0363-9997) , label(0363-9997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(0363-9997) , pack(0363-9997) , label(0363-9997)