COUNTERACT IB- ibuprofen tablet, coated 
Melaleuca, Inc

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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

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction especially in people allergic to aspirin. Symptoms may include:

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:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Adults and children 12 years and older:

Other information

Carnuba Wax, Corn Starch, Fumed Silica Gel, Hypromellose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Red Iron Oxide, Stearic Acid, Sodium Starch Glycolate, 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

Melaleuca CounterAct IB Box.jpg

Melaleuca CounterAct IB Bottle.jpg

COUNTERACT  IB
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-306
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorbrown (Brown) Scoreno score
ShapeROUND (Round) Size10mm
FlavorImprint Code Ua;0001
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-306-501 in 1 BOX08/14/2023
150 in 1 BOTTLE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209608/14/2023
Labeler - Melaleuca, Inc (139760102)

Revised: 8/2023
Document Id: 01935f28-eb3c-d489-e063-6394a90afb16
Set id: 7fafc13e-3fee-ace3-e053-2a91aa0ac2ea
Version: 3
Effective Time: 20230814
 
Melaleuca, Inc