Label: CHILDRENS NIGHTTIME COLD AND MUCUS- onion, bryonia alba root, arabica coffee bean, rumex crispus root, goldenseal, anemone pulsatilla, calcium sulfide, sulfur, phosphorus, matricaria chamomilla, euphrasia stricta, sodium chloride and silicon dioxide 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 July 7, 2018

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

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Allium Cepa 6X HPUS

    runny nose with mucus, hacking cough, sore throat

    Bryonia Alba 6X HPUS

    stubborn mucus in throat, cough with yellowish mucus

    Chamomilla 3X HPUS

    irritability, fussiness, occasional sleeplessness

    Coffea Cruda 3X HPUS

    occasional sleeplessness, restlessness

    Euphrasia Officinalis 6X HPUS

    cough with mucus in chest

    Hepar Sulph Calc 12X HPUS

    cough up mucus, mucus rattle with cough, stubborn mucus in chest

    Hydrastis 6X HPUS

    cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

    Natrum Muriaticum 6X HPUS

    accumulation of mucus in throat, cough up mucus

    Phosphorus 30X HPUS

    cough with expectoration of yellow mucus, chest congestion

    Pulsatilla 6X HPUS

    accumulation of mucus, discharge of thick yellowish mucus, loose cough

    Rumex Crispus 6X HPUS

    runny nose, sneezing

    Silicea 12X HPUS

    nasal congestion

    Sulphur 12X HPUS

    cough with thick mucus, chest congestion, nasal congestion

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

  • Drug Facts (continued)

    Uses

    Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and 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

    • 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

    Persistent cough

    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 band is broken or missing.

    In case of emergency

    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 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 49035-922-01

    Compare to

    Hyland’s 4 Kids

    Cold ’n Mucus

    Nighttime

    Equate™

    Less than 0.2% Alcohol, Sugar free, Dye Free

    Homeopathic

    Children's

    Cold & Mucus*

    Nighttime

    AGES 2 to 12 YEARS

    For Temporary Relief of:

    • Mucus & Congestion
    • Occasional Sleeplessness
    • Runny nose
    • Cough

    4 FL OZ (118 mL)

    *Claims based on traditional homeopathic practice, not

    accepted medical evidence. Not FDA evaluated.

    label2

    label1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NIGHTTIME COLD AND MUCUS 
    onion, bryonia alba root, arabica coffee bean, rumex crispus root, goldenseal, anemone pulsatilla, calcium sulfide, sulfur, phosphorus, matricaria chamomilla, euphrasia stricta, sodium chloride and silicon dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-922
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [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) PHOSPHORUS30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LICORICE (UNII: 61ZBX54883)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-922-01118 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(49035-922) , pack(49035-922) , label(49035-922)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(49035-922) , pack(49035-922) , label(49035-922)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220manufacture(49035-922) , pack(49035-922) , label(49035-922)