Label: PAIN AND FEVER - acetaminophen tablet

  • NDC Code(s): 0536-3222-01, 0536-3222-10
  • Packager: RUGBY LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 02/11

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

  • Active Ingredients (in each tablet)

    Acetaminophen 325 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily reduces fever and relives minor aches and pains caused by

    • Headache
    • muscular aches
    • common cold
    • 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 12 tablets in 24 hours,which is the maximum daily amount
    • child takes more than 5 tablets in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen 
    • adult has 3 or more alcoholic drinks every day while using this product

    Do not use

    with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if the user has

    liver disease

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • adult's pain gets worse or lasts more than 10 days
    • child's pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

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

    Keep out of reach of children

    In case of overdose, get medical help or contact a poison control center right away. Prompt 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


    Adults and children 12 years and over
    1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours.
    Children 6 to 11 years
    1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours.
    Children under 6 years
    do not use

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  • Other information

    store at room temperature

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  • INACTIVE INGREDIENT

    povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

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  • Questions or comments?

    call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday

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  • Package label Rugby pain & Fever

    Rugby®

    NDC 0536-3222-01

    COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOL®

    See New Warnings Information

    REGULAR  STRENGTH
    RELIVES

    PAIN & FEVER


    WITHOUT ASPIRIN
    Acetaminophen USP, 325 mg

    Rugby
    SATISFACTION GUARANTEED OR MONEY BACK

    100 TABLETS
    Rugby Pain & Fever 325 mg 100 tablets label

    Rugby®

    THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

    NDC 0536-3222-10

    See New Warnings Information

    FOR RELIEF OF

    PAIN & FEVER

    Acetaminophen USP, 325 mg
    Analgesic/Antipyretic

    1000 tablets

    Rugby
    satisfaction guaranteed or money back

    compare to active ingredient in extra strength tylenol®
    Rugby Pain & Fever 325 mg 1000 tablets label
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  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-3222
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    POVIDONE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color white Score no score
    Shape ROUND (round flat faced beveled edge) Size 10mm
    Flavor Imprint Code GPIA325
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3222-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:0536-3222-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 02/23/2011
    Labeler - RUGBY LABORATORIES, INC. (109178264)
    Registrant - Gemini Pharmaceuticals, Inc. (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. 055942270 manufacture
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