Label: PMS- apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum (suis), platinum metallicum, sepia, thuja occidentalis spray

  • NDC Code(s): 50845-0109-1, 50845-0109-2
  • Packager: Liddell Laboratories, 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 September 6, 2016

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

  • ACTIVE INGREDIENTS:

    Apis mellifica 200C, Chamomilla 12X, Cimicifuga racemosa 6X, Cuprum metallicum 12X, Ignatia amara 6X, Kali iodatum 200C, Magnesia phosphorica 9X, Oophorinum (suis) 30C, Platinum metallicum 12X, Sepia 9X, Thuja occidentalis 200C.

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  • USES:

    May temporarily relieves these symptoms associated with PMS:

    •irregular periods
    •pain and cramps
    •backache
    •fluid retention
    •mood swings
    •anxiety and tension
    •irritability

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  • WARNINGS:

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

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

    If pregnant or breast feeding, ask a doctor before using product.

    OTHER INFORMATION: Store at room temperature.

    Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

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  • DIRECTIONS:

    Adults and children over 12:  Spray twice under the tongue three times per day.  For severe symptoms, dosage may be taken up to six times the first day.

    Children 12 and under:  Consult a doctor prior to use.

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  • KEEP OUT OF REACH OF CHILDREN:

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

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  • INACTIVE INGREDIENTS:

    Organic alcohol 20%v/v, Purified water

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  • USES:

    May temporarily relieves these symptoms associated with PMS:


    •irregular periods
    •pain and cramps
    •backache
    •fluid retention
    •mood swings
    •anxiety and tension
    •irritability

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  • QUESTIONS:

    LIDDELL LABORATORIES

    201 APPLE BLVD.

    WOODBINE, IA 51579


    www.liddell.net

    1-800-460-7733

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  • PACKAGE LABEL DISPLAY:

    ORAL SPRAYS
    LIDDELL LABORATORIES
    EST. 1994

    08
    PmS

    Premenstrual Syndrome

    Relieves PMS symptoms: irregular periods, pain, cramps, backache, fluid retention, mood swings, anxiety, tension and irritability.

    HOMEOPATHIC


    DOCTOR FORMULATED
    Readily absorbed. Safe. No known side effects. Easy to use.

    1.0 FL OZ (30 ml)

    PMS     Label

    PMS      Carton

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  • INGREDIENTS AND APPEARANCE
    PMS 
    apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum (suis), platinum metallicum, sepia, thuja occidentalis spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0109
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 200 [hp_C]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 12 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 6 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 200 [hp_C]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 30 [hp_C]  in 1 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM 12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 9 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50845-0109-2 1 in 1 CARTON 09/06/2016
    1 NDC:50845-0109-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/18/2011
    Labeler - Liddell Laboratories, Inc. (832264241)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(50845-0109) , api manufacture(50845-0109) , label(50845-0109) , pack(50845-0109)
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