IBUPROFEN- ibuprofen tablet, coated 
REMEDYREPACK INC.

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Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug Facts

OTC - ACTIVE INGREDIENT

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

 

OTC - PURPOSE

Pain reliever/fever reducer

 

INDICATIONS & USAGE

•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

 

•if you have ever had an allergic reaction to any other pain reliever/fever reducer•right before or after heart surgery

 

•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

 

•taking aspirin to prevent 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

 

•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

 

•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

 

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.

 

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

 

DOSAGE & ADMINISTRATION

•do not take more than directed•the smallest effective dose should be used

adults and children 12 years and

older

•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

 

STORAGE AND HANDLING

•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

 

INACTIVE INGREDIENT

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

 

OTC - QUESTIONS

1-800-719-9260

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: ibuprofen


GENERIC: Ibuprofen


DOSAGE: TABLET, COATED


ADMINSTRATION: ORAL


NDC: 61786-210-20


ACTIVE INGREDIENT(S):

  • IBUPROFEN 200mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • STEARIC ACID
  • FERRIC OXIDE YELLOW
  • POLYETHYLENE GLYCOLS
  • TITANIUM DIOXIDE
  • POLYSORBATE 80
  • CROSCARMELLOSE SODIUM
  • STARCH, CORN
  • FERRIC OXIDE RED
  • HYPROMELLOSES
  • SILICON DIOXIDE


COLOR: brown


SHAPE: CAPSULE


SCORE: No score


SIZE: 15 mm


IMPRINT: I2


PACKAGING: 100 in 1 BOTTLE


OUTER PACKAGING: 1 in 1 CARTON




MM1

MM2

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-210(NDC:0904-7912)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorbrownScoreno score
ShapeCAPSULE (TABLET, COATED) Size15mm
FlavorImprint Code I2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-210-201 in 1 CARTON03/10/201503/15/2017
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209603/10/201503/15/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.