PhysiciansCare Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

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PhysiciansCare Ibuprofen

Acme United Corporation

PhysiciansCare Ibuprofen




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient (in each tablet)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Purpose

Pain reliever/fever reducer

Uses

Uses

Temporarily relieves minor aches and pains associated with
  • headache
  • toothach
  • backache
  • menstrual cramps
  • common cold
  • muscular aches
  • minor arthritis pain
Temporarily reduces fever

Warnings

Allergy alert:  Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.  Symptoms may include:

  • hives
  • skin reddening
  • asthma (wheezing)
  • facial swelling
  • rash
  • shock
  • blisters


Stomach bleeding warning:
  • 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 dinks every day whie using this product
  • take more or for a longer time than directed
o not use
  • if you have ever had an allergic reaction to any pain reliever/fever reducer
  • right before or after heart surgery
Ask a doctor before use if
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic
Ask a doctor or pharmacist before use if you are
  • taking aspirin for heart attach or dtroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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 longer than directed
Stop use and ask a doctor if

  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better





If pregnant or breast-feeding,

Directions

  • do not use more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children: (12 years or older)




Children under 12 years:

Other Information

  • read all product information before using
  • Store at 68-77°F (20-25°C)
  • avoid excessive heat 40°C (above 104°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

carnauba wax*, cellulose*, colloidal silicon dioxide, corn starch*, hypromellose, iron oxide red*, lactose, magnesium stearate, microcrystalline cellulose*, polydextrose, polyethylene glycol, povidone, silica*, sodium lauryl sulfate*, sodium starch glycolate, stearic acid*, titanium dioxide, triacetate*, triacetin*

*may contain

Questions or comments?

1-800-835-2263

PhysiciansCare Ibuprofen

Keep out of the reach of children.

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

PhysiciansCare Ibuprofen

PhysiciansCare Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0924-0074(NDC:47682-074)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOL 2000
povidone
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
white (white) 10 mm 44;352 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 2 in 1 POUCH
3 NDC:0924-0074-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075139 2011-10-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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