Label: EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, sodium bicarbonate, citric acid tablet, effervescent

  • 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 14, 2012

If you are a consumer or patient please visit this version.

  • 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)