Ibuprofen Tablet, Coated [Geritrex Llc] -

IBUPROFEN TABLET, COATED [GERITREX LLC]
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NDC	54162-941-00, 54162-941-90
Set ID	ca9498ec-755d-4a09-9504-210dd48d6fed
Category	HUMAN OTC DRUG LABEL
Packager	Geritrex LLC
Generic Name
Product Class
Product Number
Application Number	ANDA075010

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Drug Facts
Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug
Purpose

Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
- toothache
- the common cold
- menstrual cramps
- backache
- headache
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people
allergic to aspirin. Symptoms may include:
- facial swelling
- hives
- asthma (wheezing)
- rash
- shock
- skin reddening
- 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
- take more or for a longer time than directed
- are age 60 or older
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin,
  ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
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
- 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
- stomach bleeding warning applies to you
- 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
- you have problems or serious side effects from taking pain relievers or fever reducers
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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
  - have bloody or black stools
  - vomit blood
  - feel faint
  - have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
  - chest pain
  - slurred speech
  - leg swelling
  - trouble breathing
  - weakness in one part or side of body
- 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 (1-800-222-1222) right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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
- use by expiration date on package
- store between 20°-25°C (68°-77°F)
- avoid excessive heat 40°C (104°F)
Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?

Call 1-800-736-3437 8:30 AM-5:00 PM ET, Monday-Friday
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54162-941
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54162-941-90	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2018
2	NDC:54162-941-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075010	10/15/2018

Labeler - Geritrex LLC (112796248)

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Medic

IBUPROFEN TABLET, COATED [GERITREX LLC]

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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