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IBUPROFEN by REMEDYREPACK INC.

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: REMEDYREPACK INC.
NDC Code: 61786-948

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Pain reliever / fever reducer

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

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colloidal silicon dioxide, croscamellose sodiium, iron oxide red, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium


do not take more than directed

the smallest effective dose should be used

do not take longer than 10 days, unless directed by a docter
(see Wanings)

adults and children 12 years and olderChildren under 12 years

take 1 tablet every 4 to 6 hours while symptoms persistif 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.

ask a doctor

temporarily relieves minor aches and pain due to :backache,headache,menstrual cramps, minor pain of arthritismuscular aches, the common cold, toothache, temporarily reduces fever

Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include: asthma (wheezing),blisters,facial swelling,hives,rash,shock,skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:are age 60 or older; have bad stomach ulcers or bleeding problems;take a blood thinning (anticoagulant) or steroid drug; take other drug containing prescription NSAID (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.

PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-948-02

COLOR: brown

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: 114

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • IBUPROFEN 200mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POLYVINYL ALCOHOL
  • POLYETHYLENE GLYCOLS
  • STARCH, PREGELATINIZED CORN
  • TALC
  • CROSCARMELLOSE SODIUM
  • FERRIC OXIDE RED
  • SILICON DIOXIDE
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-948(NDC:49483-601)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code114
Contains    
Packaging
#Item CodePackage Description
1NDC:61786-948-0230 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123910/19/2016
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Medically reviewed on Dec 5, 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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