EQUATE IBUPROFEN- ibuprofen capsule, liquid filled

Equate Ibuprofen by

Drug Labeling and Warnings

Equate Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Walmart stores Inc, Marksans Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/Fever reducer

USE(S)

• 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:

Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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

• 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, or asthma
• you are taking a diuretic

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

• 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 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

OTHER REQUIRED WARNINGS

• each capsule contains: potassium 20 mg
• read all warnings and directions before use. Keep carton.
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)

PREGNANCY/BREASTFEEDING

Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn 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 over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

INACTIVE INGREDIENT(S)

Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black (ferrosoferric oxide), Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

PRINCIPAL DISPLAY PANEL

NDC: 49035-133-12

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever Reducer

(NSAID)

200mg, 20 SOFTGELS

Liquid-Filled Capsules

NDC: 49035-133-14

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 40 SOFTGELS

NDC: 49035-133-18

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever 

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 80 SOFTGELS

NDC: 49035-133-26

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever 

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 160 SOFTGELS

INGREDIENTS AND APPEARANCE

EQUATE IBUPROFEN 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-133
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
AMMONIA (UNII: 5138Q19F1X)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	133
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-133-12	20 in 1 BOTTLE
2	NDC: 49035-133-14	40 in 1 BOTTLE
3	NDC: 49035-133-18	80 in 1 BOTTLE
4	NDC: 49035-133-26	160 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079205	07/02/2014

Labeler - Walmart stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	MANUFACTURE(49035-133)