IBUPROFEN- ibuprofen capsule, liquid filled 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

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DRUG FACTS

Active ingredient (in each capsule)

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

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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

  • 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, 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

  • 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 problem or stroke:
    • chest pain
    • slurred speech
    • trouble breathing
    • leg swelling
    • weakness in one part or side of body
  • 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).

Directions

Other information

Inactive ingredients

FD&C green #3, gelatin, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol solution, white ink

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM to 5PM EST

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS®†

See New Warnings

IBUPROFEN

• Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

softgels**

(**Liquid-filled capsules)

†This product is not manufactured or distribued by Pfizer Consumer Healthcare, distributor of Advil® Liqui-Gels®.

TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,CHESAPEAKE, VA 23320

Product Label

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

ASSURED Ibuprofen 200 mg Softgels

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0745
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code PC16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0745-11 in 1 BOX01/31/2018
110 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20656801/31/2018
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 3/2018
Document Id: b8d78a3f-8026-449b-8715-a81a8f62e410
Set id: c997ded4-8fd9-46bd-a42b-22ac34d57661
Version: 2
Effective Time: 20180301
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)