Ibuprofen Softgels
FDA Label NDC 70729-509

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

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 Panelb+bbetter By Givingibuprofensoftgels20 Softgels(200 mg Each) (Ibuprofen Softgels 01)

Principal Display Panelb+bbetter By Givingibuprofensoftgels20 Softgels(200 mg Each) (Ibuprofen Softgels 01)

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

Principal Display Panelb+bbetter By Givingibuprofensoftgels40 Softgels(200 mg Each) (Ibuprofen Softgels 02)

Principal Display Panelb+bbetter By Givingibuprofensoftgels40 Softgels(200 mg Each) (Ibuprofen Softgels 02)

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