Label: CONSTIPATION SYMPTOM FORMULA- alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia 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 20, 2013

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  • Active Ingredients

    HPUS Active ingredients

    Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

    Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium sorbate, purified water.

  • Purpose

    ​HPUS active ingredients Purpose†

    ​Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Alumina...........................................................................hard, dry stools

    Bellis perennis................................................................rumbling in bowels, bloatedness

    Causticum......................................................................mucous-covered stools

    Collinsonia canadensis..................................................obstinate constipation, flatulence

    hydrastis canadensis.....................................................smarting pain in rectum, headache

    Lac defloratum...............................................................hard stools with great straining

    Natrum muriaticum........................................................pinching pain in abdomen

    Nux vomica....................................................................ineffectual urging, constant uneasiness

    plumbum metallicum......................................................hard stools with urging and spasm

    Sepia.............................................................................large, hard stools

  • Indications and Usage

    Uses for temporary relief of symptoms of constipation:

    • irregularity
    • hard, dry stools
    • great straining
    • rumbling and bloated bowels
    • mucus in stools
    • associated headache

    † as per various homeopathic Materia Medicas.

  • WARNINGS

    Warnings

    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
    • Keep out of reach of children.

    Other Information

    Tamper resistant for your protection. Use only if safety seal is intact.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Dosage and Administration

    Directions:

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth
    • Adults (12 and up): 3 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • PRINCIPAL DISPLAY PANEL

    King Bio Inc.image of carton

    3 Westside Drive

    Asheville, NC 28806

    For questions or more information about homeopathy

    Call (800) 543-3245 or safe-care.com

  • INGREDIENTS AND APPEARANCE
    CONSTIPATION SYMPTOM FORMULA 
    alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-7019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE10 [hp_X]  in 29.6 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 29.6 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 29.6 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT10 [hp_X]  in 29.6 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 29.6 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 29.6 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 29.6 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 29.6 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD10 [hp_X]  in 29.6 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-7019-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/20/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-7019)
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