PUBLIX FAST RELIEF EFFERVESCENT (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [PUBLIX SUPER MARKETS INC.]

PUBLIX FAST RELIEF EFFERVESCENT (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [PUBLIX SUPER MARKETS INC.]
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NDC 56062-421-68
Set ID 73051f16-2569-7394-e053-2991aa0a5359
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc.
Generic Name
Product Class Anti-coagulant
Product Number
Application Number PART343
  • Active ingredients (in each effervescent tablet)

    Aspirin 325 mg (NSAID)*

    Citric acid 1000 mg

    Sodium bicarbonate (heat-treated) 1916 mg

    *Nonsteroidal anti-inflammatory drug

  • Purpose

    Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

    Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

    Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid

    *Nonsteroidal anti-inflammatory drug

  • Uses

    Usesfor the temporary relief of

    ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

    ■ upset stomach with headache from overindulgence in food or drink

    ■ pain alone (headaches or body aches and pains)

  • 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 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 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

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

    ■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

  • Ask a doctor before use if

    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 you are

    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 anticoagulation (thinning the blood), diabetes, gout or arthritis

  • When using this product

    When using this product do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days

  • Stop use and ask a doctor if

    Stop use and ask a doctor if 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

    ■ an allergic reaction occurs. Seek medical help right away.

    ■ 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

    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.

    Keep out of reach of children.

  • OVERDOSAGE

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

  • Directions

    ■ do not exceed recommended dosage

    ■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

    adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hours

    60 years and over: 2 tablets every 4 hours do not exceed 4 tablets in 24 hours

    Take this product any time - morning, noon or night - when you need relief from hearburn, acid indigestion, sour stomach with headache or body aches and pains.

    Place two (2) tablets in 4 oz. of water. Dissolve tablets completely. You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.

  • Other information

    each tablet contains: sodium 524 mg

    ■ store at room temperature (59º-86ºF)

  • Inactive ingredients

    ■ none

  • Questions

    Serious side effects associated with the use of this product can be reported to the following address:

    DISTRIBUTED BY

    PUBLIX SUPER MARKETS, INC.

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

    publix.com

  • PACKAGE LABEL. PRINCIIPAL DISPLAY PANEL

    Publix Pain 36

  • INGREDIENTS AND APPEARANCE
    PUBLIX FAST RELIEF EFFERVESCENT 
    aspirin, citric acid, sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-421
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code L421
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-421-6818 in 1 CARTON11/10/2011
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34311/10/2011
    Labeler - Publix Super Markets Inc. (006922009)

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