Label: PROPRINAL- ibuprofen capsules 200 mg capsule, liquid filled

  • NDC Code(s): 50332-0130-1, 50332-0130-3, 50332-0130-4, 50332-0130-7, view more
    50332-0130-8
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 11, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    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

    Purpose
    Pain reliever/Fever reducer

  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor arthritis pain
    • the common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever

  • WARNINGS

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

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

    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

    Do not use

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

    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, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you

    • are under a doctor's care for any serious condition
    • take aspirin for heart attack or stroke (ibuprofen may decrease this benefit of aspirin)
    • take any other drug
  • WHEN USING

    When using this produc take with food or milk if stomach upset occurs

  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • fever worsens or lasts more than 3 days
    • pain worsens or lasts more than 10 days
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
    • new symptoms occur
    • redness or swelling is present
    • you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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

    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).

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed​

    the smallest effective dose should be used

    adults and children 12 years and over:

    • take 1 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 take more than 6 capsules in 24 hours, unless directed by a doctor

    children under 12 years of age : ask a doctor

  • OTHER INFORMATION

    Other information

    • each capsule contains: potassium 20 mg
    • caplets enclosed in a sealed packet

    • do not use if packet is torn, cut or open
    • store at 59° to 86°F (15°-30°C)
    • avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

  • PRINCIPAL DISPLAY PANEL

    Proprinal.jpg

  • INGREDIENTS AND APPEARANCE
    PROPRINAL 
    ibuprofen capsules 200 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    AMMONIA (UNII: 5138Q19F1X)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0130-320 in 1 BAG01/11/2017
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0130-440 in 1 BOX01/11/2017
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0130-7100 in 1 BOX01/11/2017
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0130-8200 in 1 BOX01/11/2017
    42 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:50332-0130-1300 in 1 BOX01/11/2017
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920501/11/2017
    Labeler - HART Health (069560969)