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Ibuprofen (Rugby Laboratories Inc)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE (0536-3587-01) Label Information
TABLET, COATED 250 TABLET, COATED in 1 BOTTLE (0536-3587-02) Label Information
TABLET, COATED 50 TABLET, COATED in 1 BOTTLE (0536-3587-06) Label Information
TABLET, COATED 1000 TABLET, COATED in 1 BOTTLE (0536-3587-10) Label Information

Complete Ibuprofen Information

  • Active Ingredient (in each tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Purpose

    Pain Releiver/ Fever Reducer


  • Uses

    • temporarily relieves minor aches and pains due to:
    • Headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • temporarily reduces fever

  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use an seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID which may cause sever stomach bleeding. The chance is higher if you:

    • are age 60 or oder
    • have had stomach ulders or bleeding problems
    • take blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks everyday while using this prdouct
    • take more or for a longer time than directed.

    Do not use
    • if you ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if
    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic.

    Ask a doctor or pharmacist before use if you are
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor's care for any serious condition
    • taking any other drug.

    When using this product
    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

    Stop use and ask a doctor if
    • You experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stoolos
    • have stomach pain that does not bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last more than 3 days
    • Redness or swelling is presentin the painful area
    • Any new symptoms appear

    If pregnant or breast-feeding

    ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    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)

    Directions
    • do not take more than directed
    • the smallest effective dose should be used
     Adults and children 12 years and older
    • take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used.
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
     children under 12 years
    •  ask a doctor

    :

    Other information
    • store between 20o- 25o C (68o- 77o F)
    • read all warnings and directions before use. Keep carton

  • Inactive Ingredients

    colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin


  • Questions or comments?

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


  • SPL UNCLASSIFIED SECTION

    RUGBY

    Non- Prescription strength

    Ibuprofen Tablets USP, 20 mg

    Pain Reliever/ Fever Reducer (NSAID)

    Compare to the active ingredient in ADVIL®*

    *Rugby Laboratories Inc., is not affiliated with the owner of the trademark Advil®

    Rugby Ibuprofen is distributed by Rugby Laboratories Inc.

    Duluth, Georgia 30097
    www.rugbylaboratories.com

    SAVE CARTON FOR COMPLETE DRUG FACTS INFORMATION AND WARNINGS

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT. DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING


  • Package Labeling

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN NDC: 0536-3587-10

    Non-Prescription Strength

    Ibuprofen

    Tablets USP, 200mg

    Pain Reliever/Fever Reducer (NSAID)

    1000 BROWN COATED TABLETS

    Ibuprofen
    Ibuprofen

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3587
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    stearic acid (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code G2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3587-01 100 in 1 BOTTLE
    2 NDC:0536-3587-02 250 in 1 BOTTLE
    3 NDC:0536-3587-06 50 in 1 BOTTLE
    4 NDC:0536-3587-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079174 03/01/2011
    Labeler - Rugby Laboratories Inc (109178264)