Label: ALKA-SELTZER LEMON LIME tablet, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 9, 2021

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

  • ACTIVE INGREDIENT

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

    Aspirin 325 mg (NSAID) 1…………………….……………Analgesic

    Sodium bicarbonate (heat-treated) 1700 mg.……………..Antacid


    1
    nonsteroidal anti-inflammatory drug
  • PURPOSE

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

    Aspirin 325 mg (NSAID)*.................................Analgesic
    Sodium bicarbonate (heat-treated) 1700 mg...... Antacid
    *nonsteroidal anti-inflammatory drug

  • INDICATIONS & USAGE

    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

    ● pain alone (headache or body and muscular aches and pains)

  • 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 early sign of Reye’s syndrome, a rare but serious illness.

    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

    ● 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 DOCTOR

    ● 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 DOCTOR/PHARMACIST

    ● presently taking a prescription drug. Antacids may

    interact with certain prescription drugs.

    ● taking a prescription drug for diabetes, gout, or arthritis

  • WHEN USING

    When using this product do not exceed recommended dosage

  • STOP USE

    ● an allergic reaction occurs. Seek medical help right away.

    ● 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

    ● symptoms get worse or last more than 10 days

    ● redness or swelling is present

    ● ringing in the ears or a loss of hearing occurs

    ● new symptoms occur

  • 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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ● fully dissolve 2 tablets in 4 ounces of water before taking

    adults and children 12 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24hours
    adults 60 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 4 tablets in 24 hours
    children under 12 yearsconsult a doctorconsult a doctor

  • OTHER SAFETY INFORMATION

    each tablet contains: sodium 504 mg

    ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

    ● Alka-Seltzer Lemon Lime in water contains principally the

    antacid sodium citrate and the analgesic sodium

    acetylsalicylate

  • INACTIVE INGREDIENT

    aspartame, docusate sodium, flavor, povidone, sodium benzoate

  • QUESTIONS

    Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer

    Anhydrous citric acid / Antacid
    Aspirin (NSAID) / Analgesic
    Sodium bicarbonate / Antacid
    36 EFFERVESCENT TABLETS
    Fast Relief of:
    Heartburn
    Upset Stomach
    Acid Indigestion
    with Headache
    Body Aches
    LEMON LIME

    36 EFFERVESCENT TABLETS

    ASLL

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER LEMON LIME 
    alka-seltzer lemon lime tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-4020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1700 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code Alka;Seltzer;Antacid
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-4020-3618 in 1 CARTON11/07/2014
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/07/2014
    Labeler - Bayer HealthCare LLC. (112117283)