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Regular Strength QPAP (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE, PLASTIC (0603-0263-29) Label Information
TABLET 1000 TABLET in 1 BOTTLE, PLASTIC (0603-0263-32) Label Information

Complete Regular Strength QPAP Information

  • Active ingredient (in each tablet)

    Acetaminophen 325 mg


  • Purpose

    Pain reliever/ fever reducer


  • Uses

    Temporarily reduces fever and relieves minor aches and pains caused by:

    • Common cold
    • headache
    • toothache
    • muscular aches
    • Premenstrual and menstrual cramps

  • Warnings

    Liver warning:

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

    • more than 8 tablets 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

  • 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

  • Ask a doctor before use if you have

    liver disease.


  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.


  • 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
    • Redness or swelling is present
    • New symptoms appear

    These could be signs of a serious condition.


  • If pregnant or breastfeeding,

    ask a health professional before use.


  • Keep out of reach of children.

    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.


  • Directions

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

    adults and children 12 years and over

    take 2 tablets every 4 to 6 hours while symptoms last, not more than 12 tablets in 24 hours

    children 6 years to 11 years

    take 1 tablet every 4 to 6 hours while symptoms last, not more than 5 tablets in 24 hours

    children under 6 years do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    Other information

    • store at room temperature 15° to 30°C (59° to 86°F)
    • you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.


  • Inactive ingredients

    polyvinylpyrrolidone, pregelatinized corn starch, sodium  carboxymethylcellulose/sodium starch glycolate, stearic acid


  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS DAMAGED OR MISSING

    Made in the USA

    For Qualitest Pharmaceuticals

    Huntsville, AL 35811


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of the Q-PAP Regular Strength container label

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH QPAP 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0263
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE K30 (UNII: U725QWY32X)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND (Flat Face Bevel Edge) Size 10mm
    Flavor Imprint Code 0027;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0263-29 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2011 07/31/2018
    2 NDC:0603-0263-32 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2011 05/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/02/2011 07/31/2018
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical, Inc. 078301063 MANUFACTURE(0603-0263)