EFFERVESCENT PAIN RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [WESTERN FAMILY FOODS, INC.]

EFFERVESCENT PAIN RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [WESTERN FAMILY FOODS, INC.]
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NDC 55312-469-80
Set ID 275d4196-52da-4cd1-a90c-ced7ea02526e
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods, Inc.
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • 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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