Label: SOLVES - ASPIRIN CHERRY- aspirin strip

  • 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 April 7, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each strip)

    Aspirin 81mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
    Close
  • Purposes

    Pain Reliever

    Close
  • Uses

    for temporary relief of minor aches and pains or as recommended by your doctor. Ask your doctor about other uses for Solves Strips 81mg aspirin.

    Close
  • 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), and 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, 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 or take more or for a longer time than directed.

    Do not use if you are allergic 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 a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma or had a tonsillectomy or oral surgery in the last 7 days.

    Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes, arthritis or anticoagulation.

    Stop and ask a doctor if an allergic reaction occurs (seek medical help right away), if you experience any of the following signs of stomach bleeding (feel faint, vomit blood, have bloody or black stools, stomach pain that does not get better), pain gets worse or lasts more than 10 days, fever lasts more than 3 days, redness or swelling is present, new symptoms occur, ringing in the ears or 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.

    Close
  • Directions

    take this medication by mouth. Take each dose with a full glass of water unless your doctor tells you otherwise. Adults and children 12 years and over: take 4 to 6 strips every 4 hours not to exceed 36 strips in a 24 hour period unless directed by a doctor. Children under 12: consult a doctor.

    Close
  • Other information

    store at room temperature.

    Close
  • Inactive ingredients

    Cocoa Butter, Glycerin, Lecithin (Soy), Magnasweet®100, Microcrystalline Cellulose, Natural and Artificial Flavors, Pectin, Polysorbate 60, Sodium Chloride, Sucralose, Talc and Water.

    Close
  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF SEALED POUCH IS OPEN, TORN, OR BROKEN

    Close
  • Questions?

    Call 1-855-7Solves or www.SolvesStrips.com
    You may also report serious side effects to this phone number

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by: Pace Wellness Inc.
    2040 S Alma School RD STE1, 474
    Chandler, AZ 85286-0987

    Close
  • PRINCIPAL DISPLAY PANEL - 5 Strip Pouch

    NDC 62309-777

    The evolution of wellness

    ZIPPER

    solves
    strips

    Wild Cherry Flavor
    Artificially Flavored

    ASPIRIN REGIMEN

    aspirin81mg Low Dose

    (NSAID) PAIN RELIEVER

    Dissolves Quickly • Tastes Great • Easy to Take

    DISSOLVABLE ORAL STRIPS 5 STRIPS

    Principal Display Panel - 5 Strip Pouch
    Close
  • INGREDIENTS AND APPEARANCE
    SOLVES - ASPIRIN   CHERRY
    aspirin strip
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62309-777
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    Pectin (UNII: 89NA02M4RX)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Talc (UNII: 7SEV7J4R1U)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Product Characteristics
    Color RED Score     
    Shape RECTANGLE Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62309-777-01 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 05/01/2014
    Labeler - Pace Wellness Inc. (079275105)
    Establishment
    Name Address ID/FEI Business Operations
    Cure Pharmaceutical Inc. 019599644 MANUFACTURE(62309-777)
    Close