Label: COUGH CONTROL- aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera rotundifolia, ferrum phosphoricum, hepar sulphuris calcareum, iodium, kali bichromicum, mephitis mephitica, nux vomica, phosphorus, pulsatilla, rumex crispus, sanguinaria canadensis, spongia tosta, sulphur 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 November 9, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera rotundifolia, Ferrum phosphoricum, Hepar sulphuris calcareum, Iodium, Kali bichromicum, Mephitis mephitica, Nux vomica, Phosphorus, Pulsatilla, Rumex crispus, Sanguinaria canadensis, Spongia tosta, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of cough symptoms: dry or hoarse cough, hacking, barking, tickling or spasmodic cough, croupy cough, throat irritation, excess mucus. Note: If cough persists for more than one week, consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults: 3 sprays 3 times per day.
    • Children: 2-12: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses: for temporary relief of cough symptoms:

    • dry or hoarse cough
    • hacking, barking, tickling or spasmodic cough
    • croupy cough
    • throat irritation
    • excess mucus
    • Note: If cough persists for more than one week, consult a doctor.
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    COUGH CONTROL 
    aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera rotundifolia, ferrum phosphoricum, hepar sulphuris calcareum, iodium, kali bichromicum, mephitis mephitica, nux vomica, phosphorus, pulsatilla, rumex crispus, sanguinaria canadensis, spongia tosta, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE10 [hp_X]  in 59 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI10 [hp_X]  in 59 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON10 [hp_X]  in 59 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER10 [hp_X]  in 59 mL
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA10 [hp_X]  in 59 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]  in 59 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE10 [hp_X]  in 59 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE10 [hp_X]  in 59 mL
    MEPHITIS MEPHITIS ANAL GLAND FLUID (UNII: 3BN57UN4US) (MEPHITIS MEPHITIS ANAL GLAND FLUID - UNII:3BN57UN4US) MEPHITIS MEPHITIS ANAL GLAND FLUID10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT10 [hp_X]  in 59 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0166-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/22/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0166)