Label: COLD FLU RELIEF BERRY CHEWABLE- pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable

  • NDC Code(s): 53499-1159-0
  • Packager: Schwabe North America, 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 October 13, 2023

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  • Active Ingredient

    PELARGONIUM SIDOIDES 1X

    ACONITUM NAPELLUS 4X

    EUCALYPTUS GLOBULUS 2X

    BRYONIA 4X

    EUPATORIUM PERFOLIATUM 6X

    GELSEMIUM SEMPERVIRENS 4X

    PHOSPHORUS 6X

    IPECACUANHA 3X

  • Inactive Ingredient

    ANNATTO SEED EXTRACT COLOR

    BEET JUICE COLOR

    CARAMEL COLOR

    LACTOSE MONOHYDRATE

    MAGNESIUM STEARATE

    MALIC ACID

    MALTODEXTRIN

    MANNITOL

    NATURAL FLAVOR

    SODIUM CROSCARMELLOSE

    SORBITOL

    STEARIC ACID

    XYLITOL

  • Indications & Usage

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

  • Purpose

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

  • Dosage and Administration

    Directions

    Chew or dissolve tablets in the mouth.  Do not swallow whole.

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

    Adults and children 13 years of age and older: Take 1 chewable tablet 3 times daily.
    Children 6-12 years of age: Take 1 chewable tablet 2 times daily.
    Children under 6 years of age: Consult a doctor.

  • 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 you are 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

    LHBN15159_A02_ColdFluRelief_Berry_20ct_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    COLD FLU RELIEF BERRY CHEWABLE 
    pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1159
    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]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ANNATTO (UNII: 6PQP1V1B6O)  
    BEET JUICE (UNII: IOZ32L9H3O)  
    CARAMEL (UNII: T9D99G2B1R)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorpink (pink with pinkish-purple specks) Scoreno score
    ShapeROUND (C) Size16mm
    FlavorBERRY (NATURAL BERRY FLAVOR) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-1159-02 in 1 CARTON07/11/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/11/2023
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-1159)
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