IBUPROFEN- ibuprofen tablet

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Prescription medication manufactured, distributed, or labeled by Apotheca, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

IBUPROFEN  
ibuprofen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12634-518(NDC:25000-114)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	114
Contains

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	02/14/2014

Labeler - Apotheca, Inc (051457844)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca, Inc		051457844	repack(12634-518)