Label: DR. PEARSALLS 500 CALORIE DIET PROTOCOL DROPS (fucus vesiculosus, cyanocobalamin, glandula suprarenalis suis, hepar suis, l-carnitine, l-ornithine, antimonium crudum, thyroidinum suis, natrum sulphuricum, pancreatinum, hypothalamus- suis, 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 February 2, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Fucus vesiculosus 2X, Cyanocolalamin (B12) 6X, Glandula suprarenalis suis (adrenal) 6X, Hepar suis (liver) 6X, L-Carnitine 6X, 12X, 30X, L-Ornithine 6X, 12X, 30X, Antimonium crudum 8X, Thyroidinum (suis) (thyroid) 8X, Natrum sulphuricum 10X, Pancreatinum 12X, Hypothalamus (suis) 18X.

  • PURPOSE

    USES:  Assist in Weight Loss and Appetite Control


  • WARNINGS

    WARNINGS:  Read, follow and do not exceed dosage directions.

    Do not use if safety seal is broken on this bottle.

    If you are under the care of a doctor, please consult them before taking this product.

    If pregnant or breast-feeding, do not use.

    Do not use if under 18 years of age.

    Stop use and ask a doctor if you have adverse reactions.

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    Store in a cool, dark place.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Adults only.  Take 12 drops under the tongue 3 times a day and hold under your tongue for 20 seconds before swallowing.  Take 20 minutes before or after food.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Green tea (leaf), Yerba mate (leaf), Ashwagandha (root), Guarana (seed), Maitake (fruit, Purified water, Ethanol 25%.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    USES:  May Assist in Weight Loss and Appetite Control.

  • QUESTIONS

    Manufactured for:

    Optimal Labs Direct LLC

    15111 N. Hayden Rd. #160-230

    Scottsdale, AZ 85260

    480-829-0154


  • PRINCIPAL DISPLAY PANEL

    DR. PEARSALLS

    500 CALORIE DIET PROTOCOL DROPS

    22 fl. oz (60 ml)

    HOMEOPATHIC

    Dr. Pearsall's 500 Calorie Diet Protocol Drops

  • INGREDIENTS AND APPEARANCE
    DR. PEARSALLS 500 CALORIE DIET  PROTOCOL DROPS
    fucus vesiculosus, cyanocobalamin, glandula suprarenalis suis, hepar suis, l-carnitine, l-ornithine, antimonium crudum, thyroidinum suis, natrum sulphuricum, pancreatinum, hypothalamus (suis), liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-1047
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS2 [hp_X]  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND6 [hp_X]  in 1 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER6 [hp_X]  in 1 mL
    LEVOCARNITINE (UNII: 0G389FZZ9M) (LEVOCARNITINE - UNII:0G389FZZ9M) LEVOCARNITINE6 [hp_X]  in 1 mL
    ORNITHINE (UNII: E524N2IXA3) (ORNITHINE - UNII:E524N2IXA3) ORNITHINE6 [hp_X]  in 1 mL
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY TRISULFIDE8 [hp_X]  in 1 mL
    THYROID, PORCINE (UNII: 6RV024OAUQ) (THYROID, PORCINE - UNII:6RV024OAUQ) THYROID, PORCINE8 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFATE10 [hp_X]  in 1 mL
    PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE - UNII:FQ3DRG0N5K) PANCRELIPASE12 [hp_X]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS18 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
    MAITAKE (UNII: A1U5YJI0Z8)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-1047-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/02/2012
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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