PAIN RELIEF FAST RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [SELECT BRAND]

PAIN RELIEF FAST RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [SELECT BRAND]
PDF | XML

NDC 15127-968-36
Set ID cdf3f813-75cd-4c9f-9585-911b080216b3
Category HUMAN OTC DRUG LABEL
Packager Select Brand
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 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)

Related Drugs