Label: BEBELYN CONSTIPATION- alumina, bryonia alba, chamomilla, nux vomica, plumbum met, silicea, sulphur 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 19, 2019

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  • Drug Facts

  • Active ingredients & Purposes

    Active ingredients** (HPUS) Purposes*
    Alumina 4C.................................................................Dry hard stool
    Bryonia alba 4C...............................................................Large stool
    Chamomilla 5C..............................................Constipation, irritability
    Nux vomica 4C.......................................Frequent ineffectual urging
    Plumbum met 4C.................................................Hard painful stools
    Silicea 4C..............................................................Straining for stool
    Sulphur 4C...................................................................Painful stools

    The letters “HPUS” indicate that this ingredient is officially included in the
    Homeopathic Pharmacopeia of the United States

  • Uses*

    • temporarily relieves the symptoms of
    • simple restlessness
    • wakeful irritability due to teething
    • helps reduce gum redness and inflammation
  • Warnings

    Stop use or ask a doctor if

    • symptoms are accompanied by high fever (greater than 101°F (38°C)
    • swelling or rash develops
    • symptoms do not improve within 3 days or worsens

    KEEP OUT OF THE REACH OF CHILDREN.

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

  • Directions

    • do not use more than directed
    • children 3 months and older: 10 drops directly on the tongue or diluted in a little water, every 4 hours or as needed
    • to preserve purity, do not touch the tip of dropper with the mouth
  • Other Information

    • store at 68-77°F (20-25°C)
    • protect from excessive heat or direct sun
    • TAMPER EVIDENT: Do not use if neck band is torn, broken or missing.
  • Inactive ingredients

    citric acid, glycerin USP, potassium sorbate, purified water.

  • Questions or comments?

    1-866-359-3478 (M-F)
    9 AM to 5 PM Eastern or www.pharmadel.com

  • Principal Display Panel

    Bebelyn

    Relieves / Alivia:

    Constipatio / Estreñimient

    WITH CHAMOMILE / CON MANZANILLA

    Homeopathic Remedy / Remedio Homeopático

    Natural

    3 months & older
    3 meses y mayores

    0.5 FL Oz (15 mL)

    Constipation

  • INGREDIENTS AND APPEARANCE
    BEBELYN CONSTIPATION 
    alumina, bryonia alba, chamomilla, nux vomica, plumbum met, silicea, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD4 [hp_C]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE4 [hp_C]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR4 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_C]
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE5 [hp_C]
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE4 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-037-011 in 1 CARTON01/09/2017
    11 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/09/2017
    Labeler - Pharmadel LLC (030129680)
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