Ibuprofen Capsule, Liquid Filled [Sam's West, Inc.] -

IBUPROFEN CAPSULE, LIQUID FILLED [SAM'S WEST, INC.]
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NDC	68196-980-38, 68196-980-41
Set ID	a5e618ba-a91f-49dc-bcc9-3b08c6daee07
Category	HUMAN OTC DRUG LABEL
Packager	Sam's West, Inc.
Generic Name
Product Class
Product Number
Application Number	ANDA206568

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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
  - toothache
  - backache
  - menstrual cramps
  - the common cold
  - muscular aches
  - minor pain of arthritis
- 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
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
- 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 conditon
- 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
  - 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.
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.
- store at 20°-25°C (68°-77°F)
- avoid excessive heat above 40°C (104°F)
Inactive ingredients

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

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PRINCIPAL DISPLAY PANEL

Ibuprofen capsules, 200 mg

NDC: 68196-980-38

INGREDIENTS AND APPEARANCE

IBUPROFEN
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-980
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 GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green (Clear)	Score	no score
Shape	CAPSULE (Oblong)	Size	18mm
Flavor		Imprint Code	PC16
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68196-980-38	200 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2017
2	NDC:68196-980-41	2 in 1 PACKAGE	11/13/2017
2		200 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206568	11/13/2017

Labeler - Sam's West, Inc. (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(68196-980)

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Medic

IBUPROFEN CAPSULE, LIQUID FILLED [SAM'S WEST, INC.]

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

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