Label: HEARTBURN RELIEF- oyster shell calcium carbonate, crude, sodium phosphate, dibasic, heptahydrate, strychnos nux-vomica seed tablet, orally disintegrating

  • 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 12, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Calcarea carbonica 15X

  • Purpose

    stomach pain, cramps

  • Active Ingredients

    Natrum phosphoricum 12X

  • Purpose

    acid indigestion, heartburn

  • Active Ingredients

    Nux vomica 10X

  • Purpose

    heartburn, acid indigestion

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
    • Acid Indigestion
    • Cramps

  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Do not exceed recommended dosage.

    • Not intended for children under 2.

    • Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

    If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if:

    symptoms worsen or persist for more than 72 hours

  • Directions Adults and Children ages 2 and older:

    Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Lactose, Magnesium stearate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-605-30
    Similasan
    Heartburn Relief
    Nux Vomica Actives
    60 Dissolvable Tablets

    PRINCIPAL DISPLAY PANEL NDC 59262-605-30 Similasan Heartburn Relief Nux Vomica Actives 60 Dissolvable Tablets

  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF 
    oyster shell calcium carbonate, crude, sodium phosphate, dibasic, heptahydrate, strychnos nux-vomica seed tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-605
    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, CRUDE15 [hp_X]
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-605-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2017
    Labeler - Similasan Corporation (111566530)
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