Label: PHARBEST REGULAR STRENGTH ASPIRIN- aspirin tablet

  • NDC Code(s): 16103-365-08, 16103-365-11
  • Packager: Pharbest Pharmaceuticals, Inc
  • 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 30, 2014

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

  • Active Ingredient (in each tablet)

    Aspirin 325mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    temporarily relieves

    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • pain and fever of colds
    • minor pains of arthritis
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  • 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
    • asthma (wheezing)
    • facial swelling
    • 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 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

    • the 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 have asthma
    • you are taking a diuretic

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

    • gout
    • diabetes
    • arthritis

    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
    • allergic reaction occurs
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • fever lasts more than 3 days

    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 accidental overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • drink a full glass of water with each dose
     adults and children 12 years and over  take 1 to 2 tablets every 4 hours. Do not exceed 12 tablets in 24 hours
     children 6 to under 12 years  consult a physician

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  • Other information

    • store at 20°-25°C (68°-77°F)
    • avoid excess heat and moisture
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  • Inactive ingredients

    Corn starch

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  • Questions?

    Adverse drug event call: (866) 562-2756 (Mon- Fri 8 AM-5PM EST)

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  • PRINCIPAL DISPLAY PANEL

    Manufactured in the U.S.A

    Pharbest

    Regular Strength

    *Compare to active ingredient in Genuine Bayer® Aspirin

    Aspirin

    Pain Reliever • Fever Reducer (NSAID)

    Aspirin, 325 mg each

    image of carton
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  • INGREDIENTS AND APPEARANCE
    PHARBEST REGULAR STRENGTH ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-365
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white Score no score
    Shape ROUND (ROUND TABLET) Size 10mm
    Flavor Imprint Code PH033
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16103-365-08 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:16103-365-11 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/12/2007
    Labeler - Pharbest Pharmaceuticals, Inc (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceuticals, Inc 557054835 manufacture(16103-365) , pack(16103-365) , label(16103-365)
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