IBUPROFEN- ibuprofen capsule, liquid filled 
Cardinal Health (Leader) 70000

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Drug Facts

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)
*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 NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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 any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • trouble breathing
    • leg swelling
    • weakness in one part or side of body
  • 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

FD&C green #3, gelatin, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitan solution, sorbitol, white ink

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ADVIL® LIQUI-GELS® active ingredient†

Ibuprofen

Solubilized Capsules, 200 mg

Pain Reliever / Fever Reducer

SOFTGELS**

(**Liquid Filled Capsules)

TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of  Advil® Liquid Gels®.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product Label

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

LEADER Ibuprofen 200 mg Capsules

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code PC16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0360-21 in 1 BOX02/28/2018
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:70000-0360-11 in 1 BOX02/28/2018
220 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:70000-0360-380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20656802/28/2018
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022
Document Id: 4ac32c62-c5e5-44ee-87e8-6e69b9422817
Set id: e5b2fa58-704c-4745-aa9a-0bc76a369ce4
Version: 9
Effective Time: 20221020
 
Cardinal Health (Leader) 70000