NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]

NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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NDC 52389-242-10, 52389-242-40, 52389-242-42, 52389-242-50
Set ID a60660b2-c5db-45a0-885f-de93e655380d
Category HUMAN OTC DRUG LABEL
Packager Alva-Amco Pharmacal Companies, Inc.
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART357
  • Active ingredient (in each chewable tablet)

    Sodium citrate dihydrate 230 mg

  • Purpose

    Upset stomach reliever/antacid

  • Uses

    For the relief of nausea associated with upset/sour stomach, including that due to overindulgence in food and drink.

  • Warnings


  • DO NOT USE

    Do not use if you have Hereditary Fructose Intolerance (HFI).  This product contains fructose.

  • Ask a doctor before use if you

    • have diabetes because this product contains sugar
    • are on a sodium-restricted diet
    • have phenylketonuria because each chewable tablet contains 4.5 mg phenylalanine.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any other medications.  This product may interact with certain prescription drugs.

  • WHEN USING

    When using this product, do not take more than 24 tablets in a 24-hour period.

  • STOP USE

    Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults: 2 - 4 tablets.
    • Children:  Consult a doctor for appropriate dosage.
    • Chew tablets completely.
    • Dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor.
    • Read all package directions and warning before use and use only as directed.
    • Nauzene Chewables are intended for use by normally healthy persons only.
    • Persons under 18 years of age should use only as directed by a doctor.
  • Other information

    • Sodium content:  60 mg/tablet
    • Store at room temperature.
    • **Contents sealed:  Each round pink Nauzene chewable tablet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a foil backing.  Do not use if seal appears broken or if product contents do not match product description. Slight red speckling may occur over time.
    • Note:  Nauzene is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment.
    • You may report serious side effects to the phone number provided under Questions? below.
  • Inactive ingredients

    Aspartame, bitter masking salt, dextrose, FDC Red No. 40 Lake, flavors, food starch-modified, fructose, hypromellose, magnesium stearate, maltodextrin, povidone, silicon dioxide, stearic acid, sucrose.

  • QUESTIONS

    Questions?  1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    NauzeneChewablesPDP

  • INGREDIENTS AND APPEARANCE
    NAUZENE 
    sodium citrate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID230 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SUCROSE (UNII: C151H8M554)  
    CHERRY (UNII: BUC5I9595W)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRY (Wild Cherry Flavor) Imprint Code ALVA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-242-404 in 1 CARTON07/08/2000
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-242-423 in 1 CARTON07/06/2017
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:52389-242-505 in 1 CARTON10/01/2006
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:52389-242-101 in 1 CARTON07/15/2016
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:52389-242-564 in 1 CARTON11/16/2019
    514 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/08/2000
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

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