IBUPROFEN- ibuprofen tablet, coated 
Family Dollar (FAMILY WELLNESS)

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Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*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

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease, asthma, or 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 problem or stroke:
    • chest pain
    • slurred speech
    • leg swellin
    • trouble breathing
    • 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

colloidal silicon dioxide, corn starch, iron oxide red, macrogol/PEG, polyvinyl alcohol-part hydralyzed, povidone (k-30), sodium starch glycolate, stearic acid, talc, titanium dioxide,

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF ADVIL®†

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

COATED TABLETS

Gluten free

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil®.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product Label

Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

FAMILY WELLNESS Ibuprofen Tablets

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-568
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-568-251 in 1 BOX06/30/201704/26/2024
1250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:55319-568-101 in 1 BOX06/30/201704/26/2024
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:55319-568-501 in 1 BOX06/30/201704/26/2024
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:55319-568-52250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201704/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917406/30/201704/26/2024
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 10/2021
Document Id: 021cd732-6441-4c63-a6fb-8a7d362840ad
Set id: d024dace-3c22-4a15-962a-ce315337905a
Version: 5
Effective Time: 20211020
 
Family Dollar (FAMILY WELLNESS)