ALKA-SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [YOUR SAFETY COMPANY]

ALKA-SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [YOUR SAFETY COMPANY]
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NDC 70262-304-50
Set ID 3b37ab81-2717-4afd-8f66-89a7bed1140e
Category HUMAN OTC DRUG LABEL
Packager Your Safety Company
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purpose
    *
    nonsteroidal anti-inflammatory drug
    Anhydrous citric acid 1000 mg Antacid
    Aspirin 325 mg (NSAID)* Analgesic
    Sodium bicarbonate (heat-treated) 1916 mg Antacid
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  • Uses

    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
    • headache, body aches, and pain alone
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  • 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

    • 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

    • 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 diabetes, gout, or arthritis

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • 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

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

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  • Directions

    Directions

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

    adults and children 12 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours
    adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours
    children under 12 years consult a doctor

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  • Other information

    • each tablet contains: sodium 567 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
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  • Inactive ingredients

    none

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  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

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  • SPL UNCLASSIFIED SECTION

    Dist. by: Bayer HealthCare LLC
    Whippany, NJ 07981

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  • PRINCIPAL DISPLAY PANEL - 50 Pouch Box

    Alka-
    Seltzer®

    Anhydrous citric acid / Antacid
    Aspirin (NSAID) / Analgesic
    Sodium bicarbonate / Antacid

    Fast Relief of:
    Heartburn
    Upset Stomach
    Acid Indigestion
    with Headache
    Body Aches

    ORIGINAL

    EFFERVESCENT TABLETS

    Principal Display Panel - 50 Pouch Box
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  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ORIGINAL 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70262-304(NDC:0280-4000)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor Imprint Code ALKA;SELTZER
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70262-304-50 50 in 1 BOX
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/15/2016
    Labeler - Your Safety Company (050622331)
    Establishment
    Name Address ID/FEI Business Operations
    Your Safety Company 050622331 RELABEL(70262-304)
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