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Ibuprofen by FRED'S, INC.

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: FRED'S, INC.
NDC Code: 55315-393

Freds Pharmacy 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:
    • backache
    • muscular aches
    • toothache
    • menstrual cramps
    • headache
    • 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:

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

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:

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • 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
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, 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
    • 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
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of body
  • 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 (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
  • store between 20º-25ºC (68º-77ºF)
  • avoid excess heat 40ºC (104ºF)
  • see end flap for expiration date and lot number 

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

fred's
Pharmacy

IBUPROFEN

Ibuprofen Tablets USP,  200 mg
Pain Reliever/Fever Reducer (NSAID)

50 (ORANGE) CAPLETS

Compare to the active ingredient In: Motrin® IB Caplets

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

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

50844        ORG111639315

DISTRIBUTED BY : fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction guaranteed
Questions or comments:
1-855-331-FRED (3733)

Freds 44-393

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-393
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POLYDEXTROSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
ANHYDROUS LACTOSE 
STARCH, CORN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;393
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-393-121 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
2NDC:55315-393-571 BOTTLE in 1 CARTON
2125 TABLET, FILM COATED in 1 BOTTLE
3NDC:55315-393-151 BOTTLE in 1 CARTON
350 TABLET, FILM COATED in 1 BOTTLE
4NDC:55315-393-20225 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-393)

 
FRED'S, INC.

← See all Ibuprofen brands

Medically reviewed on Apr 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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