PAIN AND FEVER (ACETAMINOPHEN) TABLET [RUGBY LABORATORIES]

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PAIN AND FEVER (ACETAMINOPHEN) TABLET [RUGBY LABORATORIES]
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NDC 0536-3222-01, 0536-3222-10
Set ID 2eba12bc-5a03-46da-bd33-550c1c3c0955
Category HUMAN OTC DRUG LABEL
Packager RUGBY LABORATORIES
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

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

    Warnings

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

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses 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

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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 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

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    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
    • do not take more than 10 tablets in 24 hours. unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children 6 years to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 yearsask a doctor

  • STORAGE AND HANDLING

    Other information store at room temperature

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? 1-800-645-2158

  • OTHER SAFETY INFORMATION

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

  • SPL UNCLASSIFIED SECTION

    Distributed By: Rugby Laboratories

    17177 N. Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    Rugby®
    NDC 0536-3222-01
    REGULAR STRENGTH
    Pain & Fever

    Acetaminophen 325 mg Each

    See New Warnings Information & Directions

    100 TABLETS

    Rugby 3222 - APAP 325 mg Tabs

  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3222
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorImprint Code GPIA325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-3222-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/23/201106/30/2021
    2NDC:0536-3222-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/23/201104/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/23/201106/30/2021
    Labeler - RUGBY LABORATORIES (079246066)
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