Label: TONSIN- allium cepa, pulsatilla pratensis, sambucus nigra, ferrum phosphoricum, hepar sulphuris, kali muriaticum, natrum muriaticum, kali bichromicum, mercurius solubis tablet

  • 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 December 27, 2017

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  • ACTIVE INGREDIENTS (OTC- ACTIVE INGREDIENT SECTION)

    Allium cepa D3 HPUS

    Pulsatilla Pratensis D3 HPUS

    Sambucus nigra D3 HPUS

    Ferrum Phosphoricum D6 HPUS

    Hepar Sulphuris D6 HPUS

    Kali Muriaticum D6 HPUS

    Natrum Muriaticum D6 HPUS

    Kali Bichromicum D6 HPUS

    Mercurius Solubis D10 HPUS

  • PURPOSE (DOSAGE & ADMINISTRATION SECTION)

    Temporarily relieves sneezing and watery nasal discharge

    Temporarily relieves colds with loss of taste and smell

    Temporarily relieves colds and easing mucus production reducing swelling in nasal passages

    Temporarily relieves colds, runny nose, inflammation of sinus passages and throat

    Temporarily relieves runny then stuffy nose with thick slimy mucus

    Temporarily relieves sinusitus, earache, and sore throat

    Temporarily relieves sneezing, tickling in throat loss of taste and smell

    Temporarily relieves thick green/ yellow nasal discharge and glue ear

    Temporarily relieves colds, ear, eye infections and sore throat

  • USES (OTC- PURPOSE SECTION)

    Temporarily relieves symptoms associated with sinusitis, hay fever and colds. Such as: sneezing, runny nose, mucus, and minor sore throat.

  • KEEP OUT OF REACH OF CHILDREN (OTC- KEEP OUT OF REACH OF CHILDREN SECTION)

    KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS (INDICATIONS & USAGE SECTION)

    Adults and children aged 12 years or older:

    Dissolve 2 tablets in mouth 3x daily. May be taken hourly in acute cases

    Children between 2 and 12 years old:

    Dissolve 1 tablet in mouth 3x daily. May be taken hourly in acute cases.

    Infants: 1 crushed tablet diluted in cooled, boiled, water.

  • OTHER INFORMATION (INSTRUCTIONS FOR USE SECTION)

    Store below 77°F and away from direct sunlight.

  • WARNING (WARNINGS SECTION)

    These tablets contain lactose and should be used with caution by individuals with a severe sensitivity or intolerance to lactose as well as diabetics.

  • STOP USE AND ASK DOCTOR IF (OTC- STOP USE SECTION)

    if symptoms persist for more than 3 days or worsen or if sore throat persists for more that 2 days or occurs with a fever, headache, rash, nausea or vomiting.

  • ASK A DOCTOR (OTC- ASK DOCTOR SECTION)

    ASK A DOCTOR BEFORE USING IN CHILDREN UNDER 3 YEARS OF AGE

  • IF PREGNANT OR BREASTFEEDING, (OTC- PREGNANCY OR BREAST FEEDING SECTION)

    ask a health professional before use.

  • INACTIVE INGREDIENTS (INACTIVE INGREDIENT SECTION)

    Lactose monohydrate, crosscarmelose, magnesium stearate.

  • Principle Display Panel- 150 tablet container

    Tonsin Tablets Carton

  • INGREDIENTS AND APPEARANCE
    TONSIN 
    allium cepa, pulsatilla pratensis, sambucus nigra, ferrum phosphoricum, hepar sulphuris, kali muriaticum, natrum muriaticum, kali bichromicum, mercurius solubis tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70773-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 100 [hp_X]
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM6 [hp_X]  in 100 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 100 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]  in 100 [hp_X]
    ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE3 [hp_X]  in 100 [hp_X]
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS3 [hp_X]  in 100 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 100 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE6 [hp_X]  in 100 [hp_X]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS10 [hp_X]  in 100 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70773-100-151 in 1 CARTON12/25/2017
    11 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/25/2017
    Labeler - PRIVATE LABEL BRANDS CC (539043103)
    Registrant - PRIVATE LABEL BRANDS CC (539043103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbal and Homeopathic (Pty) Ltd.638215520manufacture(70773-100)
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