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

IBUPROFEN CAPSULE, LIQUID FILLED [SAM'S WEST, INC]
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NDC	68196-199-02
Set ID	f51f243a-475c-47b7-948f-aaf45c19dd66
Category	HUMAN OTC DRUG LABEL
Packager	Sam's West, Inc
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 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° 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 toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel

Compare to Advil® Liqui-Gels® Active Ingredient**

Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

200 Softgels**

**Liquid filled capsules

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLES CAP PRINTED WITH "SEAL FOR YOUR PROTECTION" IS BROKEN OR MISSING.

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE,AR 72716
Product Label

Member's Mark Ibuprofen Capsules, 200mg

INGREDIENTS AND APPEARANCE

IBUPROFEN
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-199
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:68196-199-02	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2015	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078682	05/31/2015	12/30/2021

Labeler - Sam's West, Inc (051957769)

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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

If pregnant or breast-feeding,

Keep out of reach of children.

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