Label: VIDA MIA 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 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 325 mg (NSAID)*Pain 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 by 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 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 an 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

    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

    • you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
    • you have 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
    • symptoms get worse or last more than 10 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs
    • new symptoms occur
    • 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

    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 two tablets in 4 ounces of water before taking
    Adults and children 12 years and over2 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

  • Questions or Comments?

    call 1-800-632-2993 M-F 8AM – 4:30PM MST

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    MAGELLAN
    DISTRIBUTION SOLUTIONS
    Medley, Florida 33178

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Carton

    Compare to
    Alka-Seltzer®

    Vida
    Mia

    Effervescent

    Pain
    Relief

    Aspirin (NSAID)* / Pain Reliever, Citric Acid /
    Antacid, Sodium Bicardbonate / Antacid.
    *nonsteroidal anti-inflammatory drug

    Fast Relief of:
    • Heartburn • Acid Indigestion
    • Sour Stomach with Headache
    • Body Aches and Pains

    36
    Tablets

    PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Carton
  • INGREDIENTS AND APPEARANCE
    VIDA MIA PAIN RELIEF 
    aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-205
    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:59970-205-3618 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 FINALpart34308/13/2012
    Labeler - Navarro Discount Pharmacies, LLC (094930963)
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