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Ibuprofen by Family Dollar (FAMILY WELLNESS)

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-568

Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • toothache
    • minor pain of arthritis
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever

Warnings

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
  • 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
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
    • take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • store between 20º-25ºC (68º-77ºF). Avoid excessive heat above 40ºC (104ºF).

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

FAMILY WELLNESS Ibuprofen Tablets

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-568
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
FERRIC OXIDE RED 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-568-251 BOTTLE, PLASTIC in 1 BOX
1250 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:55319-568-101 BOTTLE, PLASTIC in 1 BOX
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:55319-568-501 BOTTLE, PLASTIC in 1 BOX
350 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:55319-568-52250 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917406/30/2017
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

← See all Ibuprofen brands

Medically reviewed on Oct 18, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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