IBUPROFEN CAPSULE, LIQUID FILLED [CVS PHARMACY]

IBUPROFEN CAPSULE, LIQUID FILLED [CVS PHARMACY]
PDF | XML

NDC 59779-108-12, 59779-108-60, 59779-108-80, 59779-108-82, 59779-108-88
Set ID 18b6d487-529a-4ec4-af41-234023fb015f
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number ANDA078682
  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/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 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

    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 or asthma
    • 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
    • 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 stools
      • have stomach pain that does not get better
    • 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.

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: 
      • take1 capsule every 4 to 6 hours while symptoms persist
      • if pain or fever does not respond to 1 capsule, 2 capsules may be used
      • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • each capsule contains:potassium 20 mg
    • read all warnings and directions before use. Keep carton
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F). Protect from light.
    • do not chew or crush, or dissolve capsules before swallowing.
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, mannitol, pharmaceutical ink, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

  • Questions or comments?

    Call  1-877-753-3935 Monday-Friday 9AM to 5PM EST

  • Principal Display Panel

    Compare to the Active Ingredient in Motrin®†

    Liquid-Filled Softgels**

    IBUPROFEN

    LIQUID FILLED SOFTGELS**

    IBUPROFEN CAPSULES, 200MG 

    Pain Reliever/Fever Reducer (NSAID)*

    SOFTGELS**

    Package Contains One Bottle

    **Liquid filled capsules

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Motrin®.

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

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS.com

    1-800-SHOP CVS

  • Product Label

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

    CVS HEALTH Ibuprofen Softgels Orange

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code IB200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-108-12120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201412/31/2021
    2NDC:59779-108-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201412/31/2021
    3NDC:59779-108-8080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201412/31/2021
    4NDC:59779-108-8280 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201412/31/2021
    5NDC:59779-108-8888 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201412/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868207/31/201412/31/2021
    Labeler - CVS Pharmacy (062312574)

Related Drugs