Label: EXTRA STRENGTH QPAP- acetaminophen tablet, coated

  • NDC Code(s): 0603-0265-21, 0603-0265-32
  • Packager: Qualitest Pharmaceuticals
  • 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 05/10

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

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    • temporarily reduces fever
    • temporarily relieves minor aches and pains due to:
      • headache
      • muscular aches
      • the common cold
      • minor pain of arthritis
      • backache
      • toothache
      • premenstrual and menstrual cramps
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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
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  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product
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  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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  • Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days 
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • Keep out of reach of children.
  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor

    children under 12 years

    do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

    store at 15° to 30°C (59° to 86°F)

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

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  • Inactive ingredients

    hypromellose, povidone, pregelatinized starch, stearic acid

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  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 8/09 R9
    8273399  0029

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH QPAP 
    acetaminophen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-0265
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE  
    POVIDONE  
    STARCH, CORN  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL (capsule-shaped) Size 17mm
    Flavor Imprint Code 0029;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0265-21 1 in 1 CARTON
    1 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-0265-32 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/01/1996
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 958430845 MANUFACTURE
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