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

  • NDC Code(s): 49035-927-01
  • Packager:  Wal-Mart Stores, Inc. 
  • 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 June 25, 2018

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

  • Drug Facts

    Active Ingredients

    Active ingredientsPurpose
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
    Hepar Sulph Calc 12X HPUScold, sneezing
    Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
    Natrum Muriaticum 6X HPUSdry cough, sore throat
    Phosphorus 12X HPUS

    hoarse/dry cough, nasal congestion, chest congestion

    Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
    Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

    "HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and 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 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.

    Do not use if imprinted tamper 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, tsp = teaspoon

    Children 2 years to under 6 years

    5 mL or 1 teaspoon 6 times per day (every 4 hours)

    Children 6 years to under 12 years

    10 mL or 2 teaspoons up to 6 times per day (every 4 hours)

    Adults and children 12 years and over

    15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

  • Inactive ingredients

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

  • Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

    NDC 49035-927-01

    Equate

    Compare to

    Hyland’s 4 Kids

    Cold ’n Cough

    Alcohol Free, Sugar Free, Dye Free

    Homeopathic

    Children's

    Cold & Cough*

    Daytime

    AGES 2 to 12 YEARS

    For Temporary Relief of:

    • Nasal Congestion

    • Runny Nose

    • Sore Throat

    • Sneezing

    • Cough

    *Claims based on traditional

    homeopathic practice, not

    accepted medical evidence.

    Not FDA evaluated.

    4 FL OZ (118 mL)

    carton 1

    carton2

  • INGREDIENTS AND APPEARANCE
    COLD AND COUGH 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-927
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    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
    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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-927-011 in 1 CARTON06/01/2018
    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 homeopathic06/01/2018
    Labeler -  Wal-Mart Stores, Inc.  (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(49035-927) , pack(49035-927) , label(49035-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(49035-927) , pack(49035-927) , label(49035-927)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(49035-927) , pack(49035-927) , label(49035-927)