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Ibuprofen Softgels by Breeden Brothers, LLC

Dosage form: capsule
Ingredients: IBUPROFEN 200mg
Labeler: Breeden Brothers, LLC
NDC Code: 70729-000

Ibuprofen Softgels

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)

IBUPROFEN SOFTGELS 
ibuprofen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-000
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 
GELATIN 
ISOPROPYL ALCOHOL 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70729-000-0120 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:70729-000-0240 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20656802/01/2018
IBUPROFEN SOFTGELS 
ibuprofen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-509
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 
GELATIN 
ISOPROPYL ALCOHOL 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70729-509-32120 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20656802/01/2018
Labeler - Breeden Brothers, LLC (080131046)

 
Breeden Brothers, LLC

← See all Ibuprofen Softgels brands

Medically reviewed on Jan 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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