Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

Ibuprofen

Dosage form: capsule, coated
Ingredients: IBUPROFEN 200mg
Labeler: NASH-FINCH COMPANY
NDC Code: 70253-292

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Our Family 44-292 Delisted

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:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • 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
  • shock
  • facial swelling
  • skin reddening
  • asthma (wheezing)
  • 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 3 or more alcoholic drinks every day while using this product
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, iburpofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • 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 a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

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
  • 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
  • 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
  • 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 excessive heat 40ºC (104ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

carnauba wax, corn stach, fumed silica gel, hypromellose, lactose, 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

SAFETY SEALED
Medicine for Body Aches and Pains

Compare to the Active Ingredient of Advil®†

Our Family®
Quality Care Since 1904

Ibuprofen
TABLETS USP, (NSAID), 200 mg
PAIN RELEIVER / FEVER REDUCER

100 CAPLETS**

**Caplets (Capsule-Shaped Tablets)

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Caplets.
50844    REV0411E29212

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

Our Family 44-292

IBUPROFEN 
ibuprofen capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70253-292
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 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code44;292
Contains    
Packaging
#Item CodePackage Description
1NDC:70253-292-121 BOTTLE, PLASTIC in 1 CARTON
1100 CAPSULE, COATED in 1 BOTTLE, PLASTIC
2NDC:70253-292-151 BOTTLE, PLASTIC in 1 CARTON
250 CAPSULE, COATED in 1 BOTTLE, PLASTIC
3NDC:70253-292-081 BOTTLE, PLASTIC in 1 CARTON
324 CAPSULE, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/24/198804/02/2018
Labeler - NASH-FINCH COMPANY (006962294)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70253-292)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70253-292)

Revised: 10/2015
 
NASH-FINCH COMPANY

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.

Hide