ALKA-SELTZER LEMON LIME tablet, effervescent

Alka-Seltzer Lemon Lime by

Drug Labeling and Warnings

Alka-Seltzer Lemon Lime by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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)

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