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  5. Label Information: Equate Ibuprofen

FDA Label for Equate Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. OTHER REQUIRED WARNINGS
    11. PREGNANCY/BREASTFEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. INACTIVE INGREDIENT(S)
    15. PRINCIPAL DISPLAY PANEL

Equate Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Walmart Stores Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)



Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/Fever reducer


Use(S)



  • 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

Warnings



Allergy alert:

Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:

    Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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

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



  • the 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, or asthma
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If



  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask Doctor If



  • 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
  • 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

Other Required Warnings



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

Pregnancy/Breastfeeding



Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn 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)


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

Inactive Ingredient(S)



Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black (ferrosoferric oxide), Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate


Principal Display Panel



NDC 49035-133-12

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever Reducer

(NSAID)

200mg, 20 SOFTGELS

Liquid-Filled Capsules


ibu-sfgels-20ct - 20ct 1

ibu-sfgels-20ct - 20ct 1









NDC 49035-133-14

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 40 SOFTGELS










NDC 49035-133-18

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever 

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 80 SOFTGELS







NDC 49035-133-26

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever 

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 160 SOFTGELS







* Please review the disclaimer below.