Equate 44-393

Drug Labeling and Warnings

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated 
Wal-Mart Stores Inc

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Equate 44-393

Active ingredient (in each orange caplet)

 Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • menstrual cramps
  • backache
  • 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 an 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

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 a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• stomach bleeding warning applies to you
• you are taking a diuretic
• you have asthma
• 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
• 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

• any new symptoms appear
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have stomach pain that does not get better
  • vomit blood
  • have bloody or black stools
• 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

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 complication 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 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

• store between 20º-25ºC (68º-77ºF)
• avoid excessive heat 40ºC (104ºF)
• use by expiration date on package

Inactive ingredients

carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC: 49035-393-12

equate™

Compare to Motrin® IB Caplets Active Ingredient†

Ibuprofen
Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer
(NSAID)

**Capsule Shaped Tablets

200 mg
100 CAPLETS**       

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin® IB Caplets.
50844        REV0411A39312

Equate 44-393

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-393
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;393
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-393-12	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2002	07/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075139	04/08/2002	07/08/2019

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-393)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-393)

Revised: 8/2016

Document Id: 9cf54cea-dc16-4287-b858-95d302075f35

Set id: 2db4651e-24b2-4bfd-90cf-91bb0bfddcc2

Version: 4

Effective Time: 20160818