Label: RUGBY REGULAR STRENGTH ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 0536-1327-01, 0536-1327-06, 0536-1327-10
  • Packager: RUGBY LABORATORIES
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2024

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  • Active ingredient (in each tablet)

    Acetaminophen 325mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves 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

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

    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
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of the reach of children.

    Overdose warning:

    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
    • do not take more than 10 tablets in 24 hours, unless directe by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children 6 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

  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

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

  • Questions or comments?

    (866) 572-2756 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    Rugby®

    NDC 0536-1327-10

    *Compare to the active ingredients in Tylenol® Regular Strength*

    Regular Strength

    Acetaminophen

    325 mg 

    Pain Reliever/

    Fever Reducer

    1000 Tablets

    Rugby Regular Strength Acetaminophen Tablet

  • INGREDIENTS AND APPEARANCE
    RUGBY REGULAR STRENGTH ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1327
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PH020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1327-0650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
    2NDC:0536-1327-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
    3NDC:0536-1327-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/11/2021
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(0536-1327) , manufacture(0536-1327) , pack(0536-1327) , label(0536-1327)
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