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Ibuprofen

Apotheca, Inc

Ibuprofen Tablets, USP 200mg (NSAID)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Ibuprofen

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:12634-518(NDC:25000-114)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
brown 10 mm 114 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12634-518-74 24 in 1 BOTTLE
2 NDC:12634-518-01 100 in 1 BOTTLE
3 NDC:12634-518-10 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 2014-02-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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