EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [CARDINAL HEALTH INC.]

EFFERVESCENT ANTACID AND PAIN RELIEF (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [CARDINAL HEALTH INC.]
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NDC 37205-196-68
Set ID abd781d2-b94c-4527-91a9-5abf7bd875de
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health Inc.
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredients (in each effervescent tablet)                                      Purpose

    Aspirin 325mg NSAID* .............................................                            Pain Reliever
    Citric Acid 1000 mg ...................................................                                   Antacid
    Sodium Bicarbonate (heat-treated) 1916 mg ................                                    Antacid

    *Nonsteroidal anti-inflammatory drug

  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers should not use this drug 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 casue a sever allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 - take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for a longer time than directed.

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.  Aspirin may cause stomach bleeding.

     

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of

    ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

    ■ upset stomach with headache from overindulgence in food or drink

    ■ pain alone (headaches or body aches and pains)

  • ASK DOCTOR

    Ask a doctor before use if - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

     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 anticoagulation (thinning the blood), diabetes, gout or arthritis

  • DO NOT USE

    Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - if overly full from food or drink.  Ask a doctor if sever stomach pain occurs after taking this product.

  • 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.

  • PREGNANCY OR BREAST FEEDING

    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.

  • STOP USE

    Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better - an allergic reaction occurs. Seek medical help right away. - pain lasts for more than 10 days or gets worse - new symptoms occur - redness or swelling is present - ringing in the ears or a loss of hearing occurs

  • WHEN USING

    When using this product do not take more than 8 tables (adults) and 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days.

  • PURPOSE

    Fast Relief of: Indigestion, Upset stomach, Heartburn with headache, Body Aches and Pains.

  • DOSAGE & ADMINISTRATION

    Directions

    - do not exceed recommended dosage
    - to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

    adults and children 12 years and over
    (up to 60 years of age)
    2 tablets every 4 hours
    do not esceed 8 tablets in 24 hours
    60 year and over

    2 tablets every 4 hours
    do not exceed 4 tablets in 24 hours
  • INACTIVE INGREDIENT

    There are no inactive ingredients.

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT ANTACID AND PAIN RELIEF  
    aspirin, sodium bicarbonate, citric acid tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-196
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION1916 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code L421
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-196-6836 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34312/01/2006
    Labeler - Cardinal Health Inc. (097537435)
    Registrant - United Exchange Corporation (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd869024500manufacture(37205-196)

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