Label: BROMO SELTZER - sodium bicarbonate, anhydrous citric acid and aspirin tablet, effervescent

  • NDC Code(s): 50201-0421-2
  • Packager: Tower Laboratories Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

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  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an ealy sign of Reye's syndrome, a rare but serious illness.

    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.

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  • 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)

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  • 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 - you have a sodium-restricted diet

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  • 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

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  • 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.

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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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  • 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.

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  • 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

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  • 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.

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  • PURPOSE

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

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  • 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
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  • INACTIVE INGREDIENT

    There are no inactive ingredients.

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  • INGREDIENTS AND APPEARANCE
    BROMO SELTZER 
    aspirin, sodium bicarbonate, citric acid tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50201-0421
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (BICARBONATE ION) BICARBONATE ION 1916 mg
    ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 1000 mg
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor Imprint Code L421
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50201-0421-2 20 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 10/01/2012
    Labeler - Tower Laboratories Ltd (001587203)
    Registrant - Tower Laboratories Ltd (869024500)
    Establishment
    Name Address ID/FEI Business Operations
    Tower Laboratories Ltd 869024500 manufacture(50201-0421)
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