44 438 ROUND WHITE Images (2024)

1. Human OTC
2. Nonsteroidal Anti-inflammatory Drug

   • Drug Classes

   • Nonsteroidal Anti-inflammatory Drug

   • NONSALICYLATE NSAIs,ANTIRHEUMATIC

   • Cyclooxygenase Inhibitors

3. L.N.K. International, Inc.

   • Version History

   • Go PRO to access past versions

   • SPL 10 - Jan 29, 2024
   • SPL 9 - Jan 30, 2023
   • SPL 8 - Jan 21, 2022
   • SPL 7 - Mar 15, 2021
   • SPL 6 - Mar 18, 2020
   • SPL 5 - Mar 12, 2019
   • SPL 4 - Apr 06, 2018
   • SPL 3 - Dec 18, 2017
   • SPL 2 - Dec 09, 2016
   • SPL 1 - Dec 18, 2009

Generic: ibuprofen is used for the treatment ofArthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity

Active Ingredient (in Each White 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:ÂIbuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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

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

• are age 60 or older
• 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

Heart attack and stroke warning:ÂNSAIDs, 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 painÂreliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or feverÂreducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease,Âasthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• taking aspirin for heartÂattack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor’s care for any serious condition
• 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
  • weakness in one part or side of body
  • leg swelling
  • slurred speech
  • trouble breathing
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• any new symptoms appear
• redness or swelling is present in the painful area

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 20°-25°C (68°-77°F)
• avoid excessive heat 40°C (104°F)
• use by expiration date on package

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions Or Comments?

Call 1-800-426-9391Â8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Quality+ Plus

NDC 50844-438-16

^â€Compare to active ingredientin Motrin® IB Tablets

IBUPROFENTABLETSUSP, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

1000 Coated Tablets

Dye Free

ACTUAL SIZE

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

^â€This product is not manufactured or distributed by Johnson &Johnson Corporation, owner of the registered trademark Motrin® IBTablets.                    50844      REV1221C43816

Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788USA

Quality Plus 44-438