IBU TABS- ibuprofen tablet, film coated

IBU Tabs by

Drug Labeling and Warnings

IBU Tabs by is a Otc medication manufactured, distributed, or labeled by Rapid Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

temporarily relieves minor aches and pains 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 chances are 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.

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

• right before or after heart surgery
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
  

ASK DOCTOR

Ask a doctor before use if

• 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 stroke
• you are taking a diuretic

ASK DOCTOR/PHARMACIST

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

When using this product take with food or milk if stomach upset occurs

STOP USE

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

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 (1-800-222-1222) right away. 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

• Tamper Evident. Do not use if packet is torn or opened
• Store at controlled room temperature 20° to 25°C (68° to 77°F)
• Avoid excessive heat and humidity

INACTIVE INGREDIENT

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone,

pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBU TABS 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73659-012
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)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red (film coated)	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73659-012-01	50 in 1 BOX	04/15/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73659-012-02	125 in 1 BOX	04/15/2022
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	04/15/2022

Labeler - Rapid Care, Inc. (877432778)