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Pain and Fever (RUGBY LABORATORIES, INC.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0536-3218-01) Label Information
TABLET, COATED 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (0536-3218-10) Label Information

Complete Pain and Fever Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredient (in each captab)

    Acetaminophen 500 mg


  • PURPOSE

    Purpose

    Pain reliever/Fever reducer


  • INDICATIONS & USAGE

    Uses

    • temporarily reduces fever and relieves minor aches and pains caused by
    • headache
    • muscular aches
    • common cold
    • toothache
    • backache
    • premenstrual and menstrual cramps
    • minor pain of arthritis

  • WARNINGS

    Warnings

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

    • more than 4,000 mg acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 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 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
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • new symptoms appear

    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.

    Overdose warning: In 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.


  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed (see Overdose warning)

    adults and children 12 years and over:

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

    children under 12 years: ask a doctor


  • STORAGE AND HANDLING

    Other information store at room temperature


  • INACTIVE INGREDIENT

    Inactive ingredients hypromellose, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid


  • QUESTIONS

    Questions or comments? Call 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 0536-3218-01
    EXTRA STRENGTH
    Pain & Fever

    Acetaminophen 500 mg each
    100 CAPTABS
    Rugby 3218 -  APAP 500 mg Caplets


  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3218
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE (Capsule shaped Tablet) Size 17mm
    Flavor Imprint Code GPI;A5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3218-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/23/2011 01/31/2020
    2 NDC:0536-3218-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/23/2011 01/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/23/2011 01/31/2020
    Labeler - RUGBY LABORATORIES (079246066)