Label: CHILDRENS NIGHTTIME COLD AND COUGH- onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride 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 July 5, 2018

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  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Allium Cepa 6X HPUS

    watery/runny nose, cold, hacking cough, sore throat

    Chamomilla 6X HPUS

    sensitive, irritable, fussy, nocturnal occasional sleeplessness

    Coffea Cruda 6X HPUS

    occasional sleeplessness, restlessness

    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

    “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.

  • 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 health care professional.

    A persistent cough may be a sign of a serious condition.

    Sore throat warning

    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 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.

  • 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 at bedtime and every

    4 hours during the night or as necessary

    Children 6 years ery

    to under 12 years

    10 mL or 2 teaspoons at bedtime and every

    4 hours during the night or as necessary

    Adults and children

    12 years and over

    15 mL or 3 teaspoons at bedtime and every

    4 hours during the night or as necessary

  • Inactive ingredients

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

  • Principal Display Panel - 118 mL Bottle Label

    NDC 49035-920-01

    Compare to

    Hyland's 4 Kids

    Cold 'n Cough

    Nighttime

    Equate™

    Alcohol Free, Sugar Free, Dye Free

    Homeopathic

    Childrens

    Cold & Cough*

    Nighttime

    AGES 2 to 12 YEARS

    For Temporary Relief of:

    Chest congestion

    Occasional sleeplessness

    Runny nose

    Sore throat

    Cough

    4 FL OZ (118mL)

    *Claims based on traditional homeopathic

    practice, not accepted medical evidence.

    Not FDA evaluated.

    Label

    Label2

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NIGHTTIME COLD AND COUGH 
    onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-920-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/02/2018
    Labeler - Wal-Mart Stores, Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(49035-920) , pack(49035-920) , label(49035-920)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXGEN PHARMA, INC.079424083manufacture(49035-920) , pack(49035-920) , label(49035-920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220manufacture(49035-920) , pack(49035-920) , label(49035-920)
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