Active Ingredient (In Each Capsule)
Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Breeden Brothers, Llc for the product Ibuprofen Softgels (NDC 70729-509). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)*
*nonsteroidal anti-inflammatory drug
fever reducer (present as the free acid and potassium salt)
Drug Facts (continued)
_ 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
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
_ if you have ever had an allergic reaction to any other pain reliever/fever reducer
_ right before or after heart surgery
_ 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
_ 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
_ 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
_ 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
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Drug Facts (continued)
_ 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
_ 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)
FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink
1-800-901-2420
Product of China
b+b
better by giving
IBUPROFEN
SOFTGELS
20 Softgels
(200 mg each)
b+b
better by giving
IBUPROFEN
SOFTGELS
40 Softgels
(200 mg each)
* Please review the disclaimer below.