← See all Ibuprofen Pain Reliever/Fever Reducer brands

Ibuprofen Pain Reliever/Fever Reducer

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: Amneal Pharmaceuticals
NDC Code: 65162-770

Ibuprofen Capsules, liquid filled, 200 mg

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
  • 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 a nonsteroidal anti-inflammatory drug (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

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, or asthma
  • 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 upset stomach occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

OTC - STOP USE

Stop use and ask a doctor if

  • you experience any of the follwing signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • 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

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 (1-800-222-1222) 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 INGREDIENTS

D&C Yellow # 10, 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 printed foil under cap is broken or missing.

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY  42141

Rev. 08-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN  PAIN RELIEVER/FEVER REDUCER
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-770
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
POLYETHYLENE GLYCOL 
WATER 
POTASSIUM HYDROXIDE 
SORBITOL 
Product Characteristics
ColorTURQUOISEScoreno score
ShapeCAPSULESize8mm
FlavorImprint CodeA;77
Contains    
Packaging
#Item CodePackage Description
1NDC:65162-770-021 BOTTLE (BOTTLE) in 1 CARTON
120 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2NDC:65162-770-081 BOTTLE (BOTTLE) in 1 CARTON
280 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
3NDC:65162-770-50500 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
4NDC:65162-770-111000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20230009/15/2011
Labeler - Amneal Pharmaceuticals (123797875)
Registrant - Amneal Pharmaceuticals (123797875)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals831227777ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 02/2012
 
Amneal Pharmaceuticals

← See all Ibuprofen Pain Reliever/Fever Reducer brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)