ASSURED IBUPROFEN- ibuprofen tablet

Assured Ibuprofen by

Drug Labeling and Warnings

Assured Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pain due to:
• headache
• toothache
• backache
• menstrual cramps
• the common cold
• 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:

• 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-inflammatory 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 prescription 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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning NSAID's except
aspirin increases 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 ibuprofen or to any other pain reliever/fever reducer

• right before or after heart surgery

Ask a doctor before use if

¬ the stomach bleeding warning applies to you
¬ you have problems or serious side effects from
taking pain relievers or fever reducers
¬ 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

¬ 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
¬ the risk of heart attack or stroke may increase if you
use more than directed or for longer than directed

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:

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

STOP USE

¬ chest pain ¬ trouble breathing
¬ leg swelling ¬ slurred speech
¬ 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

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. In case of overdose, get
medical help or contact a Poison Control Center right
away. (1-800-222-1222)

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
doctor (see Warnings)
¬ adults and children 12 years and over: take 1 caplet
every 4 to 6 hours while symptoms persist
¬ if pain or fever does not respond to 1 caplet, 2
caplets may be used
¬ do not exceed 6 caplets in 24 hours, unless directed
by a doctor
¬ children under 12 years: ask a doctor

Other information

¬ read all warnings and directions before use.
¬ store between 20°-25°C (68°-77°F)
¬ avoid excessive heat above 40°C (104°F)

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Inactive ingredients

colloidal silicon
dioxide, FD&C Yellow #6, hypromellose, maize
starch, polydextrose, polyethylene glycol,
povidone k30, pregelatinized starch, sodium
starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

ASSURED IBUPROFEN
Compare to active ingredient in Mortin® IB CAPLETS †
NDC: 68210-0011-4
Ibuprofen
Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

Actual Size
40 Caplets
†This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Motrin® IB Caplets

INGREDIENTS AND APPEARANCE

ASSURED IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0011
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 YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0011-4	1 in 1 CARTON	02/25/2019
1		40 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	ANDA202312	02/25/2019

Labeler - Spirit Pharmaceuticals LLC (179621011)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India LTD.		918609236	manufacture(68210-0011)