Label: PAIN RELIEF FAST RELIEF- aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 10, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each effervescent tablet)Purpose
    *
    nonsteroidal anti-inflammatory drug
    Aspirin (NSAID)* 325 mgPain reliever
    Citric acid 1000 mgAntacid
    Sodium bicarbonate (heat-treated) 1916 mgAntacid
  • 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
  • Warnings

    Reye's syndrome

    Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert

    Aspirin may cause 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 other drugs containing prescription or nonprescription NSAID's (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for longer time than directed

    Alcohol warning

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.

    Aspirin may cause stomach bleeding.

    Do not use: if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

    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.
    • you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.

    When using this product do not exceed the 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
    • new symptoms occur
    • redness or swelling is present
    • ringing in the ears or a loss of hearing occurs

    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.

  • Directions

    • Dissolve 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
    60 Years and over
    • 2 tablets every 4 hours, or as directed by a doctor
    • do not exceed 4 tablets in 24 hours
  • Other information

    • Each tablet contains: sodium 540 mg
    • store at room temperature. Avoid excessive heat
    • in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
  • Inactive Ingredients

    None

  • SPL UNCLASSIFIED SECTION

    Distributed by
    select brand® /SAJ Distributors
    3017 N. Midland Drive
    Pine Bluff, AR 71603

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

    NDC 15127-968-36

    select brand®
    the lower price name brand

    FAST RELIEF

    EFFERVESCENT
    Pain Relief

    Aspirin (NSAID) / Pain reliever,
    Citric acid / Antacid, Sodium bicarbonate / Antacid.

    Relieves:
    Heartburn • Acid Indigestion
    • Sour Stomach with
    Headache
    • Body Aches
    and Pain

    Compare to Active
    Ingredients in
    Alka-Seltzer    ®*

    36 EFFERVESCENT
    TABLETS

    PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF   FAST RELIEF
    aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-968
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
    Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1000 mg
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate1916 mg
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize25mm
    FlavorImprint Code C11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-968-3618 in 1 CARTON
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34310/23/2006
    Labeler - Select Brand (043562370)
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