Label: CHILDRENS COLD AND COUGH DAY AND NIGHT TWIN PACK- onion,matricaria chamomilla,arabica coffee bean,calcium sulfide,goldenseal,sodium chloride,phosphorus,anemone pulsatilla and sulfur kit

  • NDC Code(s): 49035-920-01, 49035-925-01, 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 November 14, 2019

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

  • DAYTIME

    Drug Facts

    Active ingredientsPurpose
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, sore 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 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.

    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 or accidental overdose,

    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.

  • Drug Facts (continued)

    Children 2 years

    to under 6 years

    5mL up to 6 times

    per day (every 4 hours)

    Children 6 years

    to under 12 years

    10mL up to 6 times

    per day (every 4 hours)

    Adults and children

    12 years and over

    15mL 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.
    • The inner packaged bottle is child-resistant.
    • Store at room temperature.
    • Do not refrigerate.
  • Inactive ingredients

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

  • NIGHTTIME

    Drug Facts

    Active ingredients Purpose
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, sore throat
    Chamomilla 6X HPUSsensitive, irritable, fussy, nocturnal occasional sleeplessness
    Coffea Cruda 6X HPUSoccasional sleeplessness, restlessness
    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 HPUShoarse/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 cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

  • 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

  • Drug Facts (continued)

    • 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.

    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 or accidental overdose, 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 years5mL at bedtime and every 4 hours during the night

    or as necessary

    Children 6 years to under 12 years10mL at bedtime and every 4 hours during the night or as necessary
    Adults and children 12 years and over15mL at bedtime and every 4 hours during the night or as necessary

  • 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.
    • Store at room temperature.
    • Do not refrigerate.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    *Claims based on traditional homeopathic

    practice, not accepted medical evidence.

    Not FDA evaluated.

  • Primary Principal Display Panel - Children's Cold & Cough Day & Night Value Pack

    VALUE PACK

    NDC 49035-95-01

    Equate™

    Compare to

    Hyland’s 4 Kids

    Cold ‘n Cough Day

    & Night Value Pack

    active ingredients

    Children's

    Alcohol-Free, Sugar-Free Dye-Free

    Homeopathic

    Cold & Cough*

    Daytime

    Ages 2 to12 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 (118mL) Daytime

    8 FL OZ (236mL) TOTAL

    Children's

    Alcohol-Free, Sugar-Free Dye-Free

    Homeopathic

    Cold & Cough*

    Nighttime

    Ages 2 to12 years

    For Temporary Relief of:

    • Chest congestion
    • Occasional sleeplessness
    • Runny nose
    • Sore throat
    • Sneezing
    • Cough

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    4 FL OZ (118mL) Nighttime

    Carton Value Pack

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND COUGH DAY AND NIGHT TWIN PACK 
    onion,matricaria chamomilla,arabica coffee bean,calcium sulfide,goldenseal,sodium chloride,phosphorus,anemone pulsatilla and sulfur kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-925
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-925-011 in 1 CARTON; Type 0: Not a Combination Product07/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    CHILDRENS NIGHTTIME COLD AND COUGH 
    onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquid
    Product Information
    Item Code (Source)NDC:49035-920
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-920-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/02/2018
    Part 2 of 2
    COLD AND COUGH 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Item Code (Source)NDC:49035-927
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-927-01118 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2018
    Labeler - Wal-Mart Stores, Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(49035-925)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(49035-925) , pack(49035-925) , label(49035-925)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(49035-925) , pack(49035-925) , label(49035-925)