IBUPROFEN- ibuprofen tablet, coated 
United Natural Foods, Inc. dba UNFI

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1112C-ELN-2023-0517

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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 ibuprofen or 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, kidney disease, asthma, or had a stroke
  • 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

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

■ 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

Inactive ingredients

colloidal silicon dioxide, corn starch, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-877-932-7984

PRINCIPAL DISPLAY PANEL

EQUALINE®

compare to Motrin®IB active ingredient†

NDC 41163-312-02

ibuprofen

tablets, 200mg

pain reliever/fever reducer

(NSAID)

50 coated caplets** **capsule-shaped tablets

actual size

image description

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize14mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-312-021 in 1 CARTON01/01/2020
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:41163-312-031 in 1 CARTON01/01/2020
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:41163-312-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231201/01/2020
Labeler - United Natural Foods, Inc. dba UNFI (943556183)

Revised: 5/2023
Document Id: fbe573d6-e131-8c02-e053-6294a90a3f1f
Set id: 8fed1f86-49a0-4747-e053-2a95a90a42b8
Version: 3
Effective Time: 20230517
 
United Natural Foods, Inc. dba UNFI