Label: COLD FLU RELIEF BERRY syrup

  • 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 February 9, 2024

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  • Active Ingredients

    Pelargonium sidoides 1X

    Aconitum napellus 4X

    Eucalyptus globulus 2X

    Bryonia 4X

    Eupatorium perfoliatum 6X

    Gelsemium sempervirens 4X

    Phosphorus 6X

    Ipecacuanha 3X

  • Inactive Ingredient

    Aronia Juice
    Citiric Acid
    Ethyl Alcohol
    Glycerin
    Lactose Monohydrate
    Maltodextrin
    Natural Flavor
    Potassium Sorbate
    Purified Water
    Sorbitol

  • Dosage & Administration

    Directions

    For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

    Shake well before each use.

    Use only with enclosed dosage cup.

    Adults & children 13 years of age and older: Take 1½ teaspoon (tsp) (7.5 mL) three times daily.

    Children 6 to 12 years of age: Take 1 teaspoon (5 mL) three times daily.

    Children under 6 years of age: consult a doctor.

  • Purpose

    Temporarily relieves flu symptoms.

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

  • Indications & Usage

    Temporarily relieves flu symptoms.

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

  • Warnings

    Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Ask Doctor

    Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

  • Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    LHBN15148_B01_ColdFluRelief_Berry_Syrup_4oz_CTN_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    COLD FLU RELIEF BERRY 
    cold flu relief berry syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 120 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 120 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 120 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 120 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 120 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (NATURAL BERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0148-51 in 1 CARTON02/09/2024
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/09/2024
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-0148)
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