Ibuprofen Capsule, Liquid Filled [Cardinal Health (Leader) 70000] -

IBUPROFEN CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]
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NDC	70000-0197-1, 70000-0197-2
Set ID	0ba4c1a3-1bc7-4bfb-acf5-05d371f506fe
Category	HUMAN OTC DRUG LABEL
Packager	Cardinal Health (Leader) 70000
Generic Name
Product Class
Product Number
Application Number	ANDA078682

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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
- 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 NSAID, which may cause severe stomach bleeding. The chance is 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
- 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 or asthma
- 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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over:
  - take 1 capsule every 4 to 6 hours while symptoms persist
  - if pain or fever does not respond to 1 capsule, 2 capsules may be used
  - do not exceed 6 capsules in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- each capsule contains: potassium 20 mg
- read all warnings and directions before use. Keep carton.
- store at 20° to 25°C (68° to 77°F)
- avoid excessive heat above 40°C (104°F). Protect from light.
Inactive ingredients

FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Questions or comments?

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

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

SOFTGELS

(Liquid Filled Capsules)

COMPARE TO ADVIL® LIQUI-GELS® active ingredient**

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR 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® Liqui-Gels®.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

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

LEADER Ibuprofen Capsules 200mg

INGREDIENTS AND APPEARANCE

IBUPROFEN
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0197
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	IB200
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0197-1	1 in 1 BOX	11/30/2016	12/31/2023
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:70000-0197-2	1 in 1 BOX	11/30/2016	12/31/2023
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product