Lil' Drug Store® Ibuprofen

Lil' Drug Store® Ibuprofen

Drug Labeling and Warnings

Drug Details

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LIL DRUG STORE IBUPROFEN- ibuprofen tablet 
Lil Drug Store Products, Inc

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Lil' Drug Store® Ibuprofen

Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)1


  • 1 nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever/fever reducer

    Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
      • minor pain of arthritis
    • 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 and seek medical help right away.

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding.

    The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • the 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, kidney disease, asthma or had a stroke
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of the body
      • slurred speech
      • leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in 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 during the last 3 months of pregnancy unless definitely 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 20°-25°C (68°-77°F). Avoid excessive heat above 40°C (104°F).

    Inactive ingredients

    colloidal silicon dioxide, corn starch, iron oxide red, macrogol/PEG, polyvinyl alcohol-part. hydrolyzed, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

    Questions or comments?

    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

    Product distributed by:
    Lil' Drug Store Products, Inc.
    1201 Continental Place NE
    Cedar Rapids, IA 52402

    PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton

    QUALITY
    GUARANTEED

    Compare to the Active
    Ingredient in Advil® **

    See New Warnings

    Ibuprofen
    Tablets USP, 200 mg
    Pain Reliever/Fever Reducer (NSAID)

    ACTUAL SIZE

    24
    Coated
    Tablets

    Lil'
    Drug Store
    ®

    PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton
    LIL DRUG STORE IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-6839
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 66715-6839-41 in 1 CARTON07/20/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/10/2015
    Labeler - Lil Drug Store Products, Inc (093103646)

    Revised: 12/2017
     
    Lil Drug Store Products, Inc


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