Label: NAUZENE- sodium citrate tablet, chewable

  • NDC Code(s): 52389-242-10, 52389-242-40, 52389-242-42, 52389-242-50
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC 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 April 29, 2019

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  • Active ingredient (in each chewable tablet)

    Sodium citrate dihydrate 230 mg

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  • Purpose

    Upset stomach reliever/antacid

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  • Uses

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

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  • Warnings
  • DO NOT USE

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

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  • 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.
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  • 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.

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  • WHEN USING

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

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  • STOP USE

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

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • 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.
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  • 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.
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  • 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.

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    NAUZENE 
    sodium citrate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-242
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 230 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score no score
    Shape ROUND Size 16mm
    Flavor CHERRY (Wild Cherry Flavor) Imprint Code ALVA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-242-40 4 in 1 CARTON 07/08/2000
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:52389-242-42 3 in 1 CARTON 07/06/2017
    2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:52389-242-50 5 in 1 CARTON 10/01/2006
    3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:52389-242-10 1 in 1 CARTON 07/15/2016
    4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/08/2000
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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