IBUPROFEN SOFTGELS- ibuprofen capsule

Ibuprofen Softgels by

Drug Labeling and Warnings

Ibuprofen Softgels by is a Otc medication manufactured, distributed, or labeled by Breeden Brothers, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)* 

*nonsteroidal anti-inflammatory drug

Purpose

fever reducer (present as the free acid and potassium salt)

Drug Facts (continued)

Uses

_ temporarily relieves minor aches and pains due to:

_ muscular aches

_ the common cold

_ headache

_ toothache

_ backache

_ menstrual cramps

_ 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:

_ blisters

_ rash

_ hives

_ asthma (wheezing)

_ shock

_ skin reddening

_ facial swelling

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:

_ take a blood thinning (anticoagulant) or

Drug Facts (continued)

steroid drug

_ are age 60 or older

_ have had stomach ulcers or bleeding problems

_ 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

_ stomach bleeding warning applies to you

_ you have a history of stomach problems, such as heartburn

_ you are taking a diuretic

Drug Facts (continued)

_ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or 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

_ taking any other drug

_ under a doctor's care for any serious condition

_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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

Drug Facts (continued)

stomach bleeding:

_ feel faint

_ have stomach pain that does not get better

_ have bloody or black stools

_ vomit blood

_ 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)

Drug Facts (continued)

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

Other information

_ each capsule contains: potassium 28 mg

_ read all warnings and directions before use.

_ store at 20°-25°C (68°-77°F)

_ avoid excessive heat above 40°C (104°F)

Drug Facts (continued)

Inactive ingredients

FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink

Questions or comments?

1-800-901-2420

Product of China

PRINCIPAL DISPLAY PANEL

b+b
better by giving
IBUPROFEN
SOFTGELS
20 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANEL

b+b
better by giving
IBUPROFEN
SOFTGELS
40 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANEL

NDC: 70729-509-32
b+b
IBUPROFEN
SOFTGELS
120 Softgels
(200 mg each)

INGREDIENTS AND APPEARANCE

IBUPROFEN SOFTGELS 
ibuprofen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70729-000
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70729-000-01	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018
2	NDC: 70729-000-02	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206568	02/01/2018

IBUPROFEN SOFTGELS 
ibuprofen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70729-509
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70729-509-32	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206568	02/01/2018

Labeler - Breeden Brothers, LLC (080131046)