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Ibuprofen by AAA Pharmaceutical, Inc.

Medically reviewed on December 6, 2017

Dosage form: tablet, coated
Ingredients: Ibuprofen 200mg
Labeler: AAA Pharmaceutical, Inc.
NDC Code: 57344-112

Ibuprofen Tablets

Drug Facts

Active ingredient (in each caplet)

Ibuprofen, USP 200 mg (NSAID)


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
  • 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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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
  • 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
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
adults and children 12 years and over
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
  • ask a doctor

Other information
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • read all warnings and directions before use
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

RESTORE u

NDC 57344-112-03

†COMPARE TO THE
ACTIVE INGREDIENT
IN MOTRIN IB®

Ibuprofen
Tablets, USP 200 mg

Pain Reliever, Fever Reducer
(NSAID)

100 COATED CAPLETS** (**capsule-shaped tablets)

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-112(NDC:57910-402)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
starch, corn 
hypromelloses 
FD&C yellow NO. 6 
aluminum oxide 
magnesium stearate 
cellulose, microcrystalline 
polydextrose 
polyethylene glycols 
povidone K30 
sodium starch glycolate type A corn 
stearic acid 
talc 
titanium dioxide 
triacetin 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize15mm
FlavorImprint CodeIBU;200
Contains    
Packaging
#Item CodePackage Description
1NDC:57344-112-011 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:57344-112-021 BOTTLE, PLASTIC in 1 CARTON
250 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:57344-112-031 BOTTLE, PLASTIC in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:57344-112-041 BOTTLE, PLASTIC in 1 CARTON
4250 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:57344-112-102 BOTTLE, PLASTIC in 1 CARTON
5100 TABLET, COATED in 1 BOTTLE, PLASTIC
6NDC:57344-112-08225 TABLET, COATED in 1 BOTTLE, PLASTIC
7NDC:57344-112-05500 TABLET, COATED in 1 BOTTLE, PLASTIC
8NDC:57344-112-061000 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135512/04/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
NameAddressID/FEIOperations
AAA Pharmaceutical, Inc.010411533PACK(57344-112)

 
AAA Pharmaceutical, Inc.

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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.

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