REAL RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEA) LIQUID [LABORATOIRE ATLAS INC]

REAL RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEA) LIQUID [LABORATOIRE ATLAS INC]
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NDC 63388-920-44, 63388-920-45, 63388-920-49
Set ID fde58df6-a4b4-4d8b-b607-53d56a43bc6a
Category HUMAN OTC DRUG LABEL
Packager Laboratoire Atlas Inc
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredients HPUS:

    Drosera 1C (Sundew)

    Arnica montana 3C (Leopards Bane)

    Bryonia 3C (White Bryony)

    Cetraria islandica 1C (Iceland Moss)

    Coccus cacti 3C (Cochineal)

    Corallium rubrum 3C (Red Coral)

    Stannum metallicum 3C (Tin)

    Camomilla 4C (German Chamomille)

    Coffea crudea 4C (coffee)

    The letters "HPUS" indicate that the components in this product are officially

    monographed in the Homeopathic Pharcopoeia of the United States

  • PURPOSE

    Purpose

    Drosera 1C (Sundew)................................................dry cough

    Arnica montana 3C (Leopard's Bane)...........................aches and pains, chest congestion

    Bryonia 3C (White Bryony) .......................................painful cough

    Cetraria islandica 1C (Iceland Moss)...........................cough with expectoration

    Coccus cacti 3C (Cochineal)......................................cough with expectoration

    Corallium rubrum 3C (Red Coral)..............................painful cough

    Stannum metallicum 3C (Tin)...................................cough, chills, and lessens mucus

    Camomilla 4C (German Chamomille).........................restlessness, irritability, nocturnal awakenings

    Coffea crudea 4C (coffee)........................................restlessness and sleeplessness

  • INDICATIONS & USAGE

    Uses This homeopathic medicine is made from a combination

    of ingredients traditionally used to help relieve

    symptoms associated with nighttime cough and cold*:

    •dry cough •cough with expectoration

    •chest congestion •fever •aches and pains

  • WARNINGS

    Warnings

    Stop use and ask a doctor if •Pain & cough gets worse

    or lasts more than 5 days

    •Fever gets worse or lasts more than 3 days •Redness

    or swelling is present •New symptoms occur •Cough

    comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition

    If you are pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental

    overdose, contact a medical professional or a poison

    control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions •Do not exceed recommended dosage •Do not take with

    food •Take before bedtime. Repeat every 8 hours as needed and reduce

    with improvement or as directed by a health care professional.

    Age.....................................................................Dose

    Adults and Children 12 + years...............................10 ml or 2 teaspoons (tsp)

    Children 6 to 11 years of age..................................5 ml or 1 teaspoon (tsp)

    Children 2 to 5 years of age....................................2.5 ml or 1/2 teaspoon (tsp)

  • STORAGE AND HANDLING

    Other information •do not use if seal is broken or missing

    •Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients Purified water, sorbitol,

    caramel, sodium benzoate, potassium sorbate, citric acid

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    REAL RELIEF 
    drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63388-920
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP1 [hp_C]  in 100 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]  in 100 mL
    BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 100 mL
    CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R) CORALLIUM RUBRUM WHOLE3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE4 [hp_C]  in 100 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63388-920-451 in 1 CARTON03/03/2018
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63388-920-491 in 1 CARTON03/03/2018
    2250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:63388-920-4430 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/2018
    Labeler - Laboratoire Atlas Inc (247880834)
    Registrant - Laboratoire Atlas Inc (247880834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Atlas Inc247880834manufacture(63388-920)

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