Label: EFFERVESCENT PAIN 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 October 7, 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 severe 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 a blood thinning (anticoagulant) or steroid drug
    • 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 any other pain reliever/fever reducer
    • you are allergic to aspirin

    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

    Ask a doctor or pharmacist before use if

    • 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 do not exceed the recommended dosage

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away
    • you have 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
    • pain lasts for more than 10 days or gets worse
    • 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

    • completely dissolve tablets in 4 ounces of water before taking
    Adults and children
    12 years and over    		2 tablets every 4 hours do not exceed 8 tablets in 24 hours
    60 years and older2 tablets every 4 hours do not exceed 4 tablets in 24 hours
  • Other Information

    • each tablet contains: sodium 540 mg
    • protect from excessive heat
    • in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
  • Inactive Ingredients

    none

  • SPL UNCLASSIFIED SECTION

    Proudly Distributed by
    Western Family Foods, Inc.
    P.O. Box 4057, Portland, OR 97208 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

    WESTERN
    FAMILY®

    Antacid & Pain Relief Medicine
    Effervescent
    PAIN RELIEF

    Aspirin (NSAID) / Pain Reliever, Citric Acid /
    Antacid, Sodium Bicarbonate / Antacid

    FAST RELIEF OF:

    Acid Indigestion, Upset Stomach, Heartburn
    With Headache, Body Aches & Pains

    36
    TABLETS

    COMPARE TO ALKA-SELTZER®active ingredients*

    PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT PAIN RELIEF 
    aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-469
    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:55312-469-8018 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 FINALpart34301/28/2008
    Labeler - Western Family Foods, Inc. (192166072)
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