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  5. Label Information: Ibuprofen

FDA Label for Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. WARNINGS
    4. DO NOT USE
    5. ASK DOCTOR/PHARMACIST
    6. PREGNACNCY OR BREAST FEEDING
    7. KEEP OUT OF REACH OF CHILDREN
    8. INACTIVE INGREDIENTS
    9. QUESTIONS
    10. PRINCIPAL DISPLAY PANEL

Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Apotheca, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug


Purpose



Pain reliever / fever reducer


Use(s)

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


Warnings



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

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


    • If an allergic reaction occurs, stop use and seek medical help right away.
    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the 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 Doctor/Pharmacist



Ask a doctor before use if you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older


    • Ask a doctor or pharmacist before use if you are

    • taking any other drugs containg an NSAID (prescription or nonprescription)
    • taking a blood thining (anticoagulant) or steriod drug
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attacks 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
      • long term continuous use may increase the risk of heart attack or stroke


        • Stop use and ask doctor if

        • you feel faint, vomit blood, or have bloody or black stools
          • These are signs of stomach bleeding.
          • pain gets worse or lasts more than 10 days
          • fever gets worse or lasts more than 3 days
          • stomach pain or upset gets worse or lasts
          • redness or swelling is present in painful area
          • any new symptoms appear

Pregnacncy 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 a 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 PoisonControlCenter right away. (1-800-222-1222)


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.


Questions



Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a docter 

    • 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 0c (68-77 0 F).

    • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing

Principal Display Panel



Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY11755, USA

Manufactured by:
Marksans Pharma Ltd.
Verna, Goa-403722, India

Repackaged and Distributed by:
Apotheca, Inc.
Phoenix, AZ 85006

Repackaged and Distributed for:

RejuviLife

Phoenix, AZ 85015

NDC 12634-518-74

IBUPROFEN

MAXIMUM STRENGTH

WITHOUT A PRESCRIPTION 

BROWN COATED TABLETS

Pain Reliver

Fever Reducer

RejuviLife®

24 TABLETS 200MG

LABEL - 12634 518 74013

LABEL - 12634 518 74013


* Please review the disclaimer below.