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Ibuprofen by Salado Sales, Inc.

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Salado Sales, Inc.
NDC Code: 57243-291

CVP 44-291

Active ingredient (in each brown tablet)

Ibuprofen USP,
200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • 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:

  • facial swelling
  • shock
  • skin reddening
  • blisters
  • hives
  • rash
  • 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 a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • are age 60 or older
  • take other drug containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • 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
    • 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
  • trouble breathing
  • leg swelling
  • slurred speech
  • 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 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • store between 20º-25ºC (68º-77ºF)
  • avoid excessive heat 40ºC (104ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, fumed silica gel, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, 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

CVP®  
HEALTH

COMPARE TO ADVIL® TABLETS
ACTIVE INGREDIENT

IBUPROFEN
Ibuprofen Tablets USP,
200 mg

PAIN RELIEVER
FEVER REDUCER
(NSAID)

50
COATED TABLETS
200 mg EACH

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

This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil® Tablets.       
50844   REV1116S29115

Distributed by Consumer Value Products, Inc.
P.O. Box 6115,Temple, Texas 76503
CVPproducts.com

CVP 44-291

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-291
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
CARNAUBA WAX 
STARCH, CORN 
ANHYDROUS LACTOSE 
FERRIC OXIDE RED 
SILICON DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:57243-291-151 BOTTLE, PLASTIC in 1 CARTON
150 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/1988
Labeler - Salado Sales, Inc. (009830555)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(57243-291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(57243-291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(57243-291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(57243-291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(57243-291)

Revised: 09/2017
 
Salado Sales, 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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