COUNTERACT IB- ibuprofen tablet, coated 
Melaleuca, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CounterAct IB Content of Label

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
    • 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 nonsteroidal anti-inflammatory drug (NSAID), which may cause severe 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
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • you experience any of the following signs of bleeding:
    • feel faint
    • vomit blood
    • have blood ro 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

  • Store between 20 to 25°C (68 to 77°F)
  • Read all warnings and directions before use
  • save carton for complete drug facts information and warnings

Inactive ingredients  Anhydrous lactose, carnauba wax, colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, corn starch, titanium dioxide.

Questions of comments?  call 1-800-282-3000

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

iblabelgemini.jpgibboxgemini.jpg

COUNTERACT  IB
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-183
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorbrown (Brown) Scoreno score
ShapeROUND (Round) Size10mm
FlavorImprint Code IP140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-183-501 in 1 BOX01/01/2018
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/30/201105/02/2016
Labeler - Melaleuca, Inc (139760102)

Revised: 1/2019
 
Melaleuca, Inc