Label: CRITICAL CARE ASPIRIN TO GO- aspirin powder

  • NDC Code(s): 51596-006-01, 51596-006-05, 51596-006-10, 51596-006-12, view more
    51596-006-24
  • Packager: Breakthrough Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (per powder)

    Aspirin 325mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever

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  • Uses

    Temporarily relieves:

    • headache
    • toothache
    • pain of colds
    • muscle pain
    • menstrual pain
    • minor pain of arthritis
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  • Warnings

    Reye's syndrome

    Children and teenagers who have or are recovering from chickenpox 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
    • 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 longer 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking a prescription for:

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs (seek medical help right away)
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever lasts more than 3 days
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs
    • 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.

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  • Directions

    adults and children 12 years and over:

    • see instructions in red box for opening packet
    • place 1-2 powders on the tongue and swallow with or without water
    • repeat every 4-6 hours, while symptoms persist
    • do not take more than 8 powders in 24 hours

    children under 12 years: ask a doctor

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  • Inactive ingredients

    acesulfame potassium, citric acid, flavor, glucose, sucralose

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  • Questions?

    1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

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  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx®
    Breakthrough Products, Inc.
    Denver, CO 80202

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  • PRINCIPAL DISPLAY PANEL - 325 mg Pouch Label

    New!

    Be prepared.
    Discover the
    life saving
    benefits of
    aspirin.

    Ask your doctor.

    NO
    WATER
    REQUIRED
    POUR DIRECTLY IN MOUTH

    SEE OPENING INSTRUCTIONS ON BACK PANEL

    CRITICAL
    CARE
    325
    mg

    URGENT Rx®

    ASPIRIN
    TO-GO

    ASPIRIN (NSAID) /
    PAIN RELIEVER

    lemon-lime

    distributed by UrgentRx
    1 POWDER PACK

    PRINCIPAL DISPLAY PANEL - 325 mg Pouch Label
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  • INGREDIENTS AND APPEARANCE
    CRITICAL CARE ASPIRIN TO GO 
    aspirin powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51596-006
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    aspirin (aspirin) aspirin 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    acesulfame potassium  
    anhydrous citric acid  
    dextrose  
    sucralose  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor LEMON (Lemon-Lime) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51596-006-05 5 in 1 BOX
    1 1 in 1 POUCH; Combination Product Type = C112160
    2 NDC:51596-006-12 12 in 1 BOX
    2 1 in 1 POUCH; Combination Product Type = C112160
    3 NDC:51596-006-24 24 in 1 BOX
    3 1 in 1 POUCH; Combination Product Type = C112160
    4 NDC:51596-006-01 1 in 1 POUCH; Combination Product Type = C112160
    5 NDC:51596-006-10 10 in 1 BOX
    5 1 in 1 PACKET; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 10/01/2012
    Labeler - Breakthrough Products Inc. (962008251)
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