Ibuprofen: Package Insert and Label Information

IBUPROFEN- ibuprofen tablet, film coated
TYA Pharmaceuticals

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.

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

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Allergy alert:

  • hives

  • facial swelling

  • asthma (wheezing)

  • shock

  • skin reddening

  • rash

  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Stomach bleeding warning:

  • have had stomach ulcers or bleeding problems

  • take a blood thinning (anticoagulant) or steroid drug

  • 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

  • take more or for a longer time 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 have

  • 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 asthma

  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • taking any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor”s care for any serious condition

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 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 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • use by expiration date on package

Inactive ingredients

carnauba wax, corn starch, 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?

(800) 616-2471

IBUPROFEN TABLET, FILM COATED

Label Image
(click image for full-size original)
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-7915(NDC:0904-7915)
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
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
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:64725-7915-1 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/24/1988
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-7915), REPACK (64725-7915)

Revised: 03/2013 TYA Pharmaceuticals

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