Label: PMS RELIEF- oyster shell calcium carbonate, crude - potassium carbonate - strychnos nux-vomica seed - sepia officinalis juice - tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 14, 2012

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Calcarea carbonica 30C, HPUSRelieves pain due to cramps
    Kali-carbonica 30C, HPUSRelieves breast tenderness
    Nux vomica 30C, HPUSRelieves irritability
    Sepia 30C, HPUSRelieves irritability and cravings

    "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

    Statement of Identity: Analgesic.

  • PURPOSE

  • Uses

    For the relief of the painful symptoms of PMS, including pain, irritability and breast tenderness.

  • Warnings

    • Do not use if outer package seal is broken.
    • Stop use and consult a doctor if symptoms persist for more than 5 days, worsen, or are accompanied by fever.
  • PREGNANCY OR BREAST FEEDING

    • If pregnant or breast-feeding, consult a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Directions

    (adults and children 12 years of age and older)

    Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.

  • Other information

    • Safe to take with all other medications.
    • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
    • Avoid humid or damp storage conditions. Close well when not in use.
  • Inactive Ingredients

    Lactose, magnesium stearate (vegetable source), stevia leaf extract.

  • DO NOT USE

  • Questions? Call toll free or email us at:

    1-888-60-B-WELL (1-888-602-9355)

    info@homeostasislabs.com

  • PRINCIPAL DISPLAY PANEL

    Box image
  • INGREDIENTS AND APPEARANCE
    PMS RELIEF 
    oyster shell calcium carbonate, crude - potassium carbonate - strychnos nux-vomica seed - sepia officinalis juice - tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47242-0051
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeDIAMOND (Rounded) Size11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47242-0051-11 in 1 PACKAGE
    150 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Homeostasis Laboratories, Inc. (010569196)
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