OTC Medication Information: Ibuprofen

IBUPROFEN- ibuprofen tablet, film coated
ARMY AND AIR FORCE EXCHANGE SERVICE

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:
    • menstrual cramps
    • toothache
    • backache
    • the common cold
    • headache
    • 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:

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

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
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs 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

  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • 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
    • 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 at 20 weeks or later in 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 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)
  • use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, 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

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Compare To The Active Ingredient
of Advil® Tablets

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

100 Coated Tablets

Tablets
Actual Size

quality value

This product is not manufactured or
distributed by PF Consumer Healthcare 1
LLC, owner of the registered trademark
Advil® Tablets.
50844 REV1221Q29112

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.,
Hauppauge, NY 11788
1-800-426-9391

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

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Exchange Select 44-291

IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-291
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;291
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55301-291-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55301-291-12)
2 NDC:55301-291-14 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:55301-291-03 1 BOTTLE, PLASTIC in 1 PACKAGE contains a BOTTLE, PLASTIC
3 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (55301-291-03)
4 NDC:55301-291-06 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075010 05/24/1988
Labeler — ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (55301-291)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (55301-291)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (55301-291)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (55301-291), pack (55301-291)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (55301-291)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (55301-291)

Revised: 06/2022 ARMY AND AIR FORCE EXCHANGE SERVICE

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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