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Ibuprofen by L.N.K. International, Inc.

Medically reviewed on July 5, 2017

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-993

Sound Body 44-393

Active ingredient (in each orange 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
    • menstrual cramps
    • backache
    • toothache
    • the common cold
    • 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:

  • have had stomach ulcers or bleeding problems
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • 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

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.

Do not use
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if
  • you are taking a diuretic
  • 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, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers


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


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
  • you have symptoms of heart problems or stroke
  • chest pain
  • weakness in one part or side of body
  • leg swelling
  • trouble breathing
  • slurred speech
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area

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 (1-800-222-1222) 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 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
  • avoid excessive heat 40°C (104°F)
  • store between 20°-25°C (68°-77°F)
  • use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

SOUND
BODY

Compare to the active ingredient
in Motrin® IB Caplets

NDC 50844-993-06

Ibuprofen

Ibuprofen Tablets USP,
200 mg

Pain reliever/Fever reducer (NSAID)

200 Caplets

This product is not manufactured or distributed byJohnson & Johnson Corporation,
owner of the registered trademark Motrin® IB Caplets.   50844     REV1116B39306

Distributed by
LNK INTERNATIONAL, INC.,
60 Arkay Drive,
Hauppauge, NY 11788 USA
V#733000
ITEM#022739306UPC

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Sound Body 44-393

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-993
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;393
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-993-06200 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-993)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-993)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-993, 50844-993)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-993, 50844-993)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-993, 50844-993)

 
L.N.K. International, 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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