IBUPROFEN- ibuprofen 200mg tablet, film coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet) - Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

pain reliever / fever reducer   

INDICATIONS & USAGE

Uses:

• temporarily relieves minor aches and pains due to:

    headache

    muscular aches

    minor pain of arthritis

    toothache

    backache

    the common cold

    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 facial swelling asthma (wheezing) shock skin reddening rash blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflamatory drug (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 presrciption 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:

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:

you have problems or serious side effects from taking pain relievers or fever reducers

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.

Ask a doctor or pharmacist before use if you are:

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

under a doctor’s care for any serious condition

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:

    feel faint vomit blood have bloody or black stools have stomach pain that does not get better

 you have symptoms of heart problems or stroke:

    chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling

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

PREGNANCY OR BREAST FEEDING

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

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 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 SAFETY INFORMATION

• Store between 20° to 25°C (68° to 77°F)
• Do not use if foil inner seal is broken or missing

INACTIVE INGREDIENT

Collodial Silicon Dioxide, FD& C Blue #2, FD& C red #40, FD& C Yellow #6, Hypromellose, Maltodextrin, Medium Chain Triglycerides, Microcrystalline Cellulose, Polydextrose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Talc, Titanium Dioxide

PRINCIPAL DISPLAY PANEL

See new Warnings

NDC-62959-750-74

Ibuprofen Tablets USP, 200mg

Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Compare active ingredient to Motrin®IB

Motrin IB is a registered trademark of Johnson & Johnson Consumer Inc.,

McNeal Consumer Healthcare Division

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen 200mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62959-750
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62959-750-74	1 in 1 CARTON	12/12/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209076	12/12/2019

Labeler - ULTRAtab Laboratories, Inc. (151051757)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(62959-750)