IBUPROFEN PAIN RELIEVER/FEVER REDUCER- ibuprofen capsule, liquid filled

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - 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

OTC - PURPOSE

Pain reliever/Fever reducer

INDICATIONS AND USAGE

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.

OTC - DO NOT USE

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

OTC - ASK DOCTOR

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

OTC - ASK DOCTOR/PHARMACIST

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

OTC - WHEN USING

When using this product

• take with food or milk if stomach upset occurs

OTC - STOP USE

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

OTC - PREGNANCY OR BREAST FEEDING

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.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

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 20º to 25ºC (68º to 77ºF)
• avoid excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENT

FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

OTC – QUESTIONS OR COMMENTS?

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

Read and keep carton for complete warnings and information.

Do not use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Distributed by: 

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

Rev. 11-2017-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC-65162-356-02

Ibuprofen Capsules, 200 mg

20 Capsules

Amneal Pharmaceuticals LLC

INGREDIENTS AND APPEARANCE

IBUPROFEN  PAIN RELIEVER/FEVER REDUCER
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-356
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	A356
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-356-02	1 in 1 CARTON	03/29/2013
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 65162-356-69	1 in 1 CARTON	03/29/2013
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 65162-356-11	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2013
4	NDC: 65162-356-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202300	03/29/2013

Labeler - Amneal Pharmaceuticals LLC (123797875)