ZEE-SELTZER ANTACID AND PAIN RELIEVER (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [ZEE MEDICAL]

ZEE-SELTZER ANTACID AND PAIN RELIEVER (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [ZEE MEDICAL]
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NDC 35418-233-67
Set ID b4549a8e-30db-4075-8a3c-aec3a26d2c29
Category HUMAN OTC DRUG LABEL
Packager ZEE MEDICAL
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Aspirin 325 mg (NSAID*) Pain reliever
    Citric acid 1000 mgAntacid
    Sodium bicarbonate (heat-treated) 1916 mgAntacid
  • Uses

    For the temporary relief of:

    • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
    • upset stomach with headache from overindulgence in food or drink
    • headache, body aches and pain alone
  • Warnings

    Reye's syndrome

    Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed

    Do not use: if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
    • taking a prescription drug for diabetes, gout, or arthritis

    When using this product do not exceed the recommended dosage

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any signs of stomach bleeding: (feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better)
    • pain lasts more than 10 days or gets worse
    • ringing in the ears or loss of hearing occurs
    • redness or swelling is present
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

  • Directions

    • completely dissolve tablets in 4 ounces of water before taking
    Adults and children 12 years and over2 tablets every 4 hours. Do not exceed 8 tablets in 24 hours
    60 years and over2 tablets every 4 hours. Do not exceed 4 tablets in 24 hours
    Children under 12 yearsAsk a doctor
  • Other information

    • each tablet contains: sodium 540 mg
    • store at 15-25°C (59-77°F)
    • avoid excessive heat above 40°C (104°F)
    • in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
  • Inactive ingredients

    none

  • Questions?

    1-800-841-8417 or zeemedical.com

  • SPL UNCLASSIFIED SECTION

    Distributed by ZEE MEDICAL, INC., Irvine, CA 92606

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

    ORIGINAL FLAVOR • EFFERVESCENT

    Zee-Seltzer
    ANTACID & PAIN RELIEVER

    Aspirin (NSAID) / Pain reliever
    Citric acid / Antacid
    Sodium bicarbonate / Antacid

    NBE
    NATIONAL
    BRAND
    EQUIVALENT

    COMPARE TO ACTIVE
    INGREDIENTS OF ALKA-SELTZER®*

    FAST RELIEF

    HEARTBURN
    ACID INDIGESTION
    SOUR STOMACH with HEADACHE
    BODY ACHES and PAINS

    36 EFFERVESCENT TABLETS

    ZEE

    1408

    PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    ZEE-SELTZER ANTACID AND PAIN RELIEVER 
    aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-233
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
    Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1000 mg
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate1916 mg
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize25mm
    FlavorImprint Code C11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-233-6718 in 1 CARTON
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34308/14/2006
    Labeler - ZEE MEDICAL (009645623)

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