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Ibuprofen by HEB

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: HEB
NDC Code: 37808-410

HEB - 1110 - 2017-1022

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

■ side effects occur.  You may report side effects to FDA at 1-800-FDA-1088.

■ 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 problems or stroke:

   ■ chest pain

   ■ trouble breathing    

   ■ weakness in one part or side of body

   ■ slurred speech

   ■ leg swelling

■ 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 over: 

   ■ take 1 caplet every 4 to 6 hours while symptoms persist

   ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used

   ■ do not exceed 6 caplets in 24 hours, unless directed by a doctor

■ children under 12 years:  ask a doctor

Other information
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information and warnings

Inactive ingredients

colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

Compare to Advil® Caplets active ingredient

NDC 37808-410-02

HEB

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

For Body Aches and Pains

Actual Size

50 COATED CAPLETS**

**Capsule-shaped Tablets

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-410
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FERRIC OXIDE RED 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE K30 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScoreno score
ShapeOVALSize15mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-410-021 BOTTLE, PLASTIC in 1 CARTON
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:37808-410-05500 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917401/01/2011
Labeler - HEB (007924756)

 
HEB

← See all Ibuprofen brands

Medically reviewed on Oct 23, 2017

Further information

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

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