Ibuprofen Capsule, Liquid Filled
FDA Label NDC 67091-185

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Ibuprofen (NDC 67091-185). 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 other, active ingredient (in each capsule), purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredient (In Each Capsule)

Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • 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

Allergy Alert

Ibuprofen may 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 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:

  • 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

Heart Attack And Stroke Warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 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, asthma, or had a stroke
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • 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

Stop Use And Ask A Doctor If

■ side effects occur.  You may report side effects to FDA at 1-800-FDA-1088.

■ 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

■ you have symptoms of heart problems or stroke:

   ■ chest pain

   ■ trouble breathing    

   ■ weakness in one part or side of body

   ■ slurred speech

   ■ leg swelling

■ 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

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

Other Information

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

Inactive Ingredients

ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

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WinCo Foods

Ibuprofen

Compare to the active ingredient in ADVIL Liqui-Gels

Relieves:  Minor Aches & Pains, Fever

IBUPROFEN CAPSULES

200 mg (NSAID)/

PAIN RELIEVER – FEVER REDUCER

80 Softgels**

** Liquid Filled Capsules

Image Description (1185a03wnc R0)

Image Description (1185a03wnc R0)

* Please review the disclaimer below.