Label: CHAMOMILA CRAMP RELIEF- matricaria recutita atropa belladonna root tobacco leaf pellet

  • 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 1, 2009

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  • Purpose

    Uses: Temporarily relieves symptoms of cramps or teething.

  • Dosage & Administration

    Directions: Dissolve under tongue. For gastrointestinal or menstrual cramps, take pellets every 15 minutes, decreasing to 4 times daily. Age 12 and older: 10 pellets. Ages 2-11: 5 pellets. For teething infants, dissolve 3-5 pellets in warm water and give hourly by mouth. Under age 2: ask a doctor.

  • OTC-Active Ingredient

    Active Ingredients: Chamomilla e rad. 3X, Belladonna e rad. 6X, Nicotiana e fol. 6X, all HPUS.

  • Inactive Ingredient

    Inactive Ingredient: Sucrose

  • Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN.

  • Do not use section

    Warnings:  Do not use if allergic to any ingredient. Do not use if safety seal is broken or missing.

  • Ask doctor section

    Consult a doctor if symptoms persist for 3 days, if you are diabetic or intolerant of sugar.

  • Pregnancy or breast feeding section

    If you are pregnant or nursing, consult a doctor before use.

  • Questions section

    Questions? Uriel Pharmacy

    866 642-2858  East Troy, WI 53120 

    www.urielpharmacy.com

    NDC 48951-3062-2

  • Principal Display Panel

    Chamomilla

    Cramp Relief

    Homeopathic Pellets

    net wt. 1 oz.

    chamomilla cramp relief pellets bottle label

  • INGREDIENTS AND APPEARANCE
    CHAMOMILA CRAMP RELIEF  
    matricaria recutita atropa belladonna root tobacco leaf pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-3062
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
    ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M) ATROPA BELLADONNA ROOT6 [hp_X]
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-3062-21350 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2009
    Labeler - Uriel Pharmacy Inc (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc043471163manufacture
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