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

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

Drug Label Information

Updated November 13, 2024

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

  • Active ingredients

    (in each effervescent tablet)

    Anhydrous citric acid 1000 mg

    Aspirin 325 mg (NSAID)*

    Sodium bicarbonate (heat-treated) 1916 mg

    *Nonsteroidal anti-inflammatory drug

  • Purpose

    Anhydrous citric acid 1000 mg ................................ Antacid

    Aspirin 325 mg (NSAID)*..........................................Pain reliever

    Sodium bicarbonate (heat-treated) 1916 mg ...........Antacid

    *Nonsteroidal anti-inflammatory drug

  • Uses

    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

    ■ headache, body aches, and pain alone

  • 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 cause a sever 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 ■ 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

  • Do not use

    Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients.

  • Ask a doctor before use if

    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 asthma ■ you have a sodium-restricted diet

  • 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

  • When using this product

    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 2 weeks, except under the advice and supervision of a physician.

  • Stop use and ask a doctor if

    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 loss of hearing occurs

  • If pregnant 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • 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 exceed 8 tablets in 24 hours

    60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours

    Children under 12 years: consult a doctor

  • Other information

    each tablet contains: sodium 524 mg

    ■ store at room temperature (59°-86°F)

  • Inactive ingredients

    ■ none

  • QUESTIONS

    Serious side effects associated with the use of this product can be reported to the following address:

    Tower Laboratories LTD.

    P.O. Box 306

    8 Industrial Park Rd.

    Centerbrook, CT 06409

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Bromo Pain 20

  • INGREDIENTS AND APPEARANCE
    BROMO SELTZER 
    aspirin, sodium bicarbonate, citric acid tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50201-0421
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 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:50201-0421-210 in 1 CARTON07/16/2012
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/16/2012
    Labeler - Tower Laboratories Ltd (001587203)
    Registrant - Tower Laboratories Ltd (869024500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd869024500manufacture(50201-0421) , pack(50201-0421) , label(50201-0421)