ShopRite Ibuprofen IB Drug Facts

ShopRite Ibuprofen IB by

Drug Labeling and Warnings

ShopRite Ibuprofen IB by is a Otc medication manufactured, distributed, or labeled by Wakefern Food Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SHOPRITE IBUPROFEN IB- ibuprofen tablet, film coated 
Wakefern Food Corporation

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ShopRite Ibuprofen IB 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 pains due to:
• headache
• muscular aches
• minor pain of arthritis
• toothache
• backache
• the common cold
• menstrual cramps
• 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 an 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

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
• the 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, or kidney disease
• you have asthma
• 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
• 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
• 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 right away. (1-800-222-1222)

Directions

• do not take more than directed
• the smallest effective dose should be used

• adults and children 12 years and older:
  • 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 at 20-25°C (68-77°F)
• avoid high humidity and excessive heat above 40°C (104°F)
• see end panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Motrin® IB

SEE NEW WARNINGS INFORMATION

IBUPROFEN IB

Ibuprofen Tablets USP, 200mg

Pain Reliever – Fever Reducer (NSAID)

FOR BODY ACHES AND PAINS

actual size

100 film coated orange caplets**

(**capsule shaped tablets)

SHOPRITE IBUPROFEN IB 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-517
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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	I2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-517-71	1 in 1 CARTON	08/19/2013	10/31/2019
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41190-517-78	1 in 1 CARTON	08/06/2013	06/30/2019
2		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	ANDA077349	08/06/2013	10/31/2019

Labeler - Wakefern Food Corporation (069722418)

Revised: 11/2019

Document Id: 397da1ef-3e6f-4852-9242-3e42b72f214d

34390-5

Set id: 7380ee70-3cec-42b5-be89-3c830ec8e9d7

Version: 2

Effective Time: 20191119

 

Wakefern Food Corporation