Hy-Vee, Inc. Ibuprofen Tablets, 200 mg Drug Facts

ibuprofen by

Drug Labeling and Warnings

ibuprofen by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated 
HyVee Inc

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Hy-Vee, Inc. Ibuprofen Tablets, 200 mg Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • 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 chances are 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

  • 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
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • 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 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
  • 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

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • see end panel for lot number and expiration date {For Carton Configuration Only}

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredient of Advil® Ibuprofen Tablets

Ibuprofen Tablets, 200 mg

See New Warnings Information

Pain Reliever/Fever Reducer (NSAID)

For Body Aches & Pains

ACTUAL SIZE

Easy to Swallow

100 TABLETS

200 mg EACH

Ibuprofen Image 1
Ibuprofen Image 2
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42507-604
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code I2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42507-604-621 in 1 CARTON03/15/199102/21/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 42507-604-711 in 1 CARTON03/15/199102/21/2019
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 42507-604-781 in 1 CARTON03/15/199103/28/2019
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 42507-604-90500 in 1 BOTTLE; Type 0: Not a Combination Product03/15/199105/13/2019
5NDC: 42507-604-851 in 1 CARTON03/15/199102/27/2010
5250 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC: 42507-604-761 in 1 CARTON03/15/199111/05/2014
6120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209603/15/199105/13/2019
Labeler - HyVee Inc (006925671)

Revised: 11/2019
 
HyVee Inc