Label: BICARUVAS- antacid powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2015

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  • Bicaruvas

    Double Action

    BICARUVAS

    .Sodium Bicarbonate

    .Calcium Carbonate

    Antiacid

    Effervescent Powder

    8 packets .17 oz (5g) ea. packet label

    Directions

    .Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor.

    Children under 12 years, consult a doctor

  • Principal Display Please see box.jpg

    principal panel

  • Active ingredients

    Active Ingredients (in each packet) Purpose

    Sodium Bicarbonate 2.452g antacid

    Citric Acid 1.927 g antiacid

    Tartaric Acid 0.220g antiacid

    Calcium Carbonate .05 g antiacid

  • Uses

    Uses for the relief of:

    Heartburn . Sour stomach . upset stomach associated with these symptoms

  • Warnings

    Warnings Do not exceed more than 5 packets in a 24 hour period

    Do not exceed more than 3 packets in 24 hours if you are 60 years or older

    the maximum dosage for more than two weeks except under the advise and supervision of a physician

  • Pregnant

    If pregnant or breat feeding, ask a helth professional before use

  • Overdose

    In case of Overdose get medical help or contact a Poison Control Center right away.

  • Inactive

    Inactive Ingredients

    grape flavor. stevia. polyethilene glycol 4000

  • Other Information

    Other Information

    each packet contains 671 mg of sodium

    each packet contains 20 mg of calcium

    store in a dry cool place

  • children

    Keep out of reach of children

  • INGREDIENTS AND APPEARANCE
    BICARUVAS 
    antacid powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69728-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H) TARTARIC ACID220 mg  in 118 mL
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION50 mg  in 118 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1827 mg  in 118 mL
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE2452 mg  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE (UNII: 6X543N684K) 150 mg  in 118 mL
    STEVIA LEAF (UNII: 6TC6NN0876) 50 mg  in 118 mL
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 150 mg  in 118 mL
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69728-0002-1118 mL in 1 PACKET; Type 0: Not a Combination Product09/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/23/2013
    Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROSANA DISTRIBUCIONES S.A. DE C.V.816197867manufacture(69728-0002)
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