IBUPROFEN- ibuprofen capsule, liquid filled 
Family Dollar (FAMILY WELLNESS)

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DRUG FACTS

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (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 or 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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

black iron oxide, FD&C green no 3, gelatin, hypromellose, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitan, sorbitol

Principal Display Panel

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

Ibuprofen 

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Softgels

(**Liquid-Filled Capsules)

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

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

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC,

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

Product Label

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

FAMILY WELLNESS Ibuprofen 200 mg Softgels

 

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-046
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)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code I200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-046-16160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/202006/30/2025
2NDC:55319-046-201 in 1 BOX06/30/202006/30/2025
220 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775306/30/202006/30/2025
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 10/2022
Document Id: 6403a89b-ae4d-42e5-9a5c-d51613f0f42a
Set id: ff13ff8f-ef17-4d08-bd44-058a080c8c61
Version: 2
Effective Time: 20221031
 
Family Dollar (FAMILY WELLNESS)