Label: B-COMBO injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 23, 2015

If you are a consumer or patient please visit this version.

  • DOSAGE FORMS & STRENGTHS

    1ml

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    B-COMBO 
    b-combo injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70104-110
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 mg  in 1 mL
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL1 mg  in 1 mL
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1 mg  in 1 mL
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1 mg  in 1 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70104-110-011 mL in 1 VIAL; Type 0: Not a Combination Product11/23/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2015
    Labeler - Perdido Key Health and Wellness Inc (079900209)
    Registrant - Perdido Key Health and Wellness Inc (079900209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Perdido Key Health and Wellness Inc079900209api manufacture(70104-110)